Teste hva som skjer når et immunterapilegemiddel (Pembrolizumab) tilsettes til stråling eller gis av seg selv sammenlignet med vanlig behandling av kjemoterapi med stråling etter kirurgi for tilbakevendende hode- og nakkeplateepitelkarsinom
En fase II randomisert studie av adjuvant terapi med Pembrolizumab etter reseksjon av tilbakevendende/andre primær hode- og nakkeplateepitelkarsinom med høyrisikoegenskaper
This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy [cisplatin and carboplatin] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
PRIMARY OBJECTIVE:
I. To evaluate overall survival (OS) of adjuvant pembrolizumab for 12 months compared to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk head and neck squamous cell carcinoma (HNSCC) patients.
SECONDARY OBJECTIVES:
I. To evaluate the following endpoints in both arms: disease free survival (DFS), locoregional control, rates of distant metastasis, toxicity.
II. To evaluate whether high PD-L1 expression (defined as Combined Positive Score [CPS] >= 20) is predictive of increased efficacy in the experimental group compared to control.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM B: Patients receive cisplatin or carboplatin intravenously (IV) on day 1. Treatment repeats every 7 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy (PBRT) once daily (QD) for a total of 30 fractions in the absence of disease progression or unacceptable toxicity.
ARM C: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 6 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity.
Patients in all arms undergo computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial.
After completion of study treatment, patients are followed up at 30 days, and then every 6 months for up to 5 years from the date of registration.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35233
- Aktiv, ikke rekrutterende
- University of Alabama at Birmingham Cancer Center
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- Rekruttering
- University of Arkansas for Medical Sciences
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 501-686-8274
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Hovedetterforsker:
- Omar T. Atiq
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California
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Anaheim, California, Forente stater, 92806
- Rekruttering
- Kaiser Permanente-Anaheim
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-398-3996
- E-post: clinical.trials@kp.org
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Hovedetterforsker:
- Aakash Batra
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Bellflower, California, Forente stater, 90706
- Rekruttering
- Kaiser Permanente-Bellflower
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-398-3996
- E-post: clinical.trials@kp.org
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Hovedetterforsker:
- Aakash Batra
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Irvine, California, Forente stater, 92612
- Aktiv, ikke rekrutterende
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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La Jolla, California, Forente stater, 92093
- Aktiv, ikke rekrutterende
- UC San Diego Moores Cancer Center
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Los Angeles, California, Forente stater, 90027
- Rekruttering
- Kaiser Permanente Los Angeles Medical Center
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-398-3996
- E-post: clinical.trials@kp.org
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Hovedetterforsker:
- Aakash Batra
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Ontario, California, Forente stater, 91761
- Rekruttering
- Kaiser Permanente-Ontario
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-398-3996
- E-post: clinical.trials@kp.org
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Hovedetterforsker:
- Aakash Batra
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Orange, California, Forente stater, 92868
- Aktiv, ikke rekrutterende
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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Roseville, California, Forente stater, 95661
- Aktiv, ikke rekrutterende
- Sutter Roseville Medical Center
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Roseville, California, Forente stater, 95661
- Aktiv, ikke rekrutterende
- Sutter Cancer Centers Radiation Oncology Services-Roseville
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San Diego, California, Forente stater, 92121
- Aktiv, ikke rekrutterende
- California Protons Cancer Therapy Center
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Connecticut
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New Haven, Connecticut, Forente stater, 06520
- Rekruttering
- Yale University
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
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Hovedetterforsker:
- Aarti Bhatia
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New Haven, Connecticut, Forente stater, 06510
- Rekruttering
- Smilow Cancer Center/Yale-New Haven Hospital
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
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Hovedetterforsker:
- Aarti Bhatia
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Trumbull, Connecticut, Forente stater, 06611
- Rekruttering
- Smilow Cancer Hospital Care Center-Trumbull
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
-
Hovedetterforsker:
- Aarti Bhatia
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Waterford, Connecticut, Forente stater, 06385
- Rekruttering
- Smilow Cancer Hospital Care Center - Waterford
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 203-785-5702
- E-post: canceranswers@yale.edu
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Hovedetterforsker:
- Aarti Bhatia
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20010
- Rekruttering
- MedStar Washington Hospital Center
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 202-877-8839
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Hovedetterforsker:
- Cristina Merkhofer
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Florida
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Coral Gables, Florida, Forente stater, 33146
- Rekruttering
- UM Sylvester Comprehensive Cancer Center at Coral Gables
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 305-243-2647
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Hovedetterforsker:
- Elizabeth A. Nicolli
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Deerfield Beach, Florida, Forente stater, 33442
- Rekruttering
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 305-243-2647
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Hovedetterforsker:
- Elizabeth A. Nicolli
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Gainesville, Florida, Forente stater, 32610
- Aktiv, ikke rekrutterende
- UF Health Cancer Institute - Gainesville
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Miami, Florida, Forente stater, 33136
- Rekruttering
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 305-243-2647
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Hovedetterforsker:
- Elizabeth A. Nicolli
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Plantation, Florida, Forente stater, 33324
- Rekruttering
- UM Sylvester Comprehensive Cancer Center at Plantation
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 305-243-2647
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Hovedetterforsker:
- Elizabeth A. Nicolli
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Tampa, Florida, Forente stater, 33607
- Rekruttering
- Moffitt Cancer Center-International Plaza
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-679-0775
- E-post: ClinicalTrials@moffitt.org
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Hovedetterforsker:
- Kedar Kirtane
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Tampa, Florida, Forente stater, 33612
- Rekruttering
- Moffitt Cancer Center - McKinley Campus
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-679-0775
- E-post: ClinicalTrials@moffitt.org
-
Hovedetterforsker:
- Kedar Kirtane
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Tampa, Florida, Forente stater, 33612
- Rekruttering
- Moffitt Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-679-0775
- E-post: ClinicalTrials@moffitt.org
-
Hovedetterforsker:
- Kedar Kirtane
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Wesley Chapel, Florida, Forente stater, 33544
- Rekruttering
- Moffitt Cancer Center at Wesley Chapel
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-679-0775
- E-post: ClinicalTrials@moffitt.org
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Hovedetterforsker:
- Kedar Kirtane
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Georgia
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Atlanta, Georgia, Forente stater, 30308
- Rekruttering
- Emory University Hospital Midtown
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 888-946-7447
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Hovedetterforsker:
- Sujith Baliga
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Atlanta, Georgia, Forente stater, 30308
- Rekruttering
- Emory Proton Therapy Center
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 404-251-2854
- E-post: allyson.anderson@emory.edu
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Hovedetterforsker:
- Sujith Baliga
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Atlanta, Georgia, Forente stater, 30322
- Suspendert
- Emory University Hospital/Winship Cancer Institute
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Savannah, Georgia, Forente stater, 31404
- Suspendert
- Memorial Health University Medical Center
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Rekruttering
- Northwestern University
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 312-695-1301
- E-post: cancer@northwestern.edu
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Hovedetterforsker:
- Jochen H. Lorch
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Chicago, Illinois, Forente stater, 60612
- Rekruttering
- University of Illinois
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 312-355-3046
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Hovedetterforsker:
- Ameen Salahudeen
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Chicago, Illinois, Forente stater, 60612
- Rekruttering
- John H Stroger Jr Hospital of Cook County
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 312-864-5204
-
Hovedetterforsker:
- Deimante M. Tamkus
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Danville, Illinois, Forente stater, 61832
- Rekruttering
- Carle at The Riverfront
-
Hovedetterforsker:
- Tanmay Sahai
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-446-5532
- E-post: Research@Carle.com
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DeKalb, Illinois, Forente stater, 60115
- Rekruttering
- Northwestern Medicine Cancer Center Kishwaukee
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 630-352-5360
- E-post: Donald.Smith3@nm.org
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Hovedetterforsker:
- Jochen H. Lorch
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Decatur, Illinois, Forente stater, 62526
- Rekruttering
- Decatur Memorial Hospital
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Hovedetterforsker:
- Bryan A. Faller
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 217-876-4762
- E-post: morganthaler.jodi@mhsil.com
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Decatur, Illinois, Forente stater, 62526
- Suspendert
- Cancer Care Specialists of Illinois - Decatur
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Effingham, Illinois, Forente stater, 62401
- Rekruttering
- Carle Physician Group-Effingham
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Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-446-5532
- E-post: Research@carle.com
-
Hovedetterforsker:
- Tanmay Sahai
-
Effingham, Illinois, Forente stater, 62401
- Rekruttering
- Crossroads Cancer Center
-
Hovedetterforsker:
- Bryan A. Faller
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 217-876-4762
- E-post: morganthaler.jodi@mhsil.com
-
Geneva, Illinois, Forente stater, 60134
- Rekruttering
- Northwestern Medicine Cancer Center Delnor
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 630-352-5360
- E-post: Donald.Smith3@nm.org
-
Hovedetterforsker:
- Jochen H. Lorch
-
Lake Forest, Illinois, Forente stater, 60045
- Aktiv, ikke rekrutterende
- Northwestern Medicine Lake Forest Hospital
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Mattoon, Illinois, Forente stater, 61938
- Rekruttering
- Carle Physician Group-Mattoon/Charleston
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-446-5532
- E-post: Research@carle.com
-
Hovedetterforsker:
- Tanmay Sahai
-
Maywood, Illinois, Forente stater, 60153
- Rekruttering
- Loyola University Medical Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 708-226-4357
-
Hovedetterforsker:
- Joseph I. Clark
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O'Fallon, Illinois, Forente stater, 62269
- Rekruttering
- HSHS Saint Elizabeth's Hospital
-
Hovedetterforsker:
- Bryan A. Faller
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 217-876-4762
- E-post: morganthaler.jodi@mhsil.com
-
Springfield, Illinois, Forente stater, 62702
- Rekruttering
- Southern Illinois University School of Medicine
-
Hovedetterforsker:
- Bryan A. Faller
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 217-545-7929
-
Springfield, Illinois, Forente stater, 62702
- Rekruttering
- Springfield Clinic
-
Hovedetterforsker:
- Bryan A. Faller
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-444-7541
-
Springfield, Illinois, Forente stater, 62781
- Rekruttering
- Springfield Memorial Hospital
-
Hovedetterforsker:
- Bryan A. Faller
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 217-528-7541
- E-post: pallante.beth@mhsil.com
-
Urbana, Illinois, Forente stater, 61801
- Rekruttering
- Carle Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-446-5532
- E-post: Research@carle.com
-
Hovedetterforsker:
- Tanmay Sahai
-
Urbana, Illinois, Forente stater, 61801
- Suspendert
- The Carle Foundation Hospital
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Warrenville, Illinois, Forente stater, 60555
- Rekruttering
- Northwestern Medicine Cancer Center Warrenville
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 630-352-5360
- E-post: Donald.Smith3@nm.org
-
Hovedetterforsker:
- Jochen H. Lorch
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Indiana
-
Richmond, Indiana, Forente stater, 47374
- Aktiv, ikke rekrutterende
- Reid Health
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-
Iowa
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Ankeny, Iowa, Forente stater, 50023
- Rekruttering
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 515-241-3305
-
Hovedetterforsker:
- Seema Harichand-Herdt
-
Clive, Iowa, Forente stater, 50325
- Rekruttering
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 515-241-3305
-
Hovedetterforsker:
- Seema Harichand-Herdt
-
Council Bluffs, Iowa, Forente stater, 51503
- Suspendert
- Heartland Oncology and Hematology LLP
-
Council Bluffs, Iowa, Forente stater, 51503
- Suspendert
- Methodist Jennie Edmundson Hospital
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Des Moines, Iowa, Forente stater, 50314
- Rekruttering
- Broadlawns Medical Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 515-282-2200
-
Hovedetterforsker:
- Seema Harichand-Herdt
-
Des Moines, Iowa, Forente stater, 50316
- Suspendert
- Iowa Lutheran Hospital
-
Des Moines, Iowa, Forente stater, 50309
- Rekruttering
- Iowa Methodist Medical Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 515-241-6727
-
Hovedetterforsker:
- Seema Harichand-Herdt
-
Des Moines, Iowa, Forente stater, 50309
- Rekruttering
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 515-241-3305
-
Hovedetterforsker:
- Seema Harichand-Herdt
-
Des Moines, Iowa, Forente stater, 50314
- Rekruttering
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 515-241-3305
-
Hovedetterforsker:
- Seema Harichand-Herdt
-
Waukee, Iowa, Forente stater, 50263
- Rekruttering
- UI Health Care Mission Cancer and Blood - Waukee Clinic
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 515-241-3305
-
Hovedetterforsker:
- Seema Harichand-Herdt
-
West Des Moines, Iowa, Forente stater, 50266-7700
- Suspendert
- Methodist West Hospital
-
-
Kansas
-
Kansas City, Kansas, Forente stater, 66160
- Aktiv, ikke rekrutterende
- University of Kansas Cancer Center
-
Overland Park, Kansas, Forente stater, 66211
- Aktiv, ikke rekrutterende
- University of Kansas Hospital-Indian Creek Campus
-
Overland Park, Kansas, Forente stater, 66210
- Aktiv, ikke rekrutterende
- University of Kansas Cancer Center-Overland Park
-
Westwood, Kansas, Forente stater, 66205
- Aktiv, ikke rekrutterende
- University of Kansas Hospital-Westwood Cancer Center
-
-
Kentucky
-
Lexington, Kentucky, Forente stater, 40536
- Rekruttering
- University of Kentucky/Markey Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 859-257-3379
-
Hovedetterforsker:
- Susanne M. Arnold
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Louisville, Kentucky, Forente stater, 40202
- Rekruttering
- The James Graham Brown Cancer Center at University of Louisville
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 502-562-3429
-
Hovedetterforsker:
- Neal E. Dunlap
-
Louisville, Kentucky, Forente stater, 40245
- Rekruttering
- UofL Health Medical Center Northeast
-
Hovedetterforsker:
- Neal E. Dunlap
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 502-852-2755
- E-post: ctoinfo@louisville.edu
-
-
Maryland
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Baltimore, Maryland, Forente stater, 21201
- Rekruttering
- University of Maryland/Greenebaum Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-888-8823
-
Hovedetterforsker:
- Matthew J. Ferris
-
Baltimore, Maryland, Forente stater, 21201
- Suspendert
- Maryland Proton Treatment Center
-
Columbia, Maryland, Forente stater, 21044
- Rekruttering
- Central Maryland Radiation Oncology in Howard County
-
Hovedetterforsker:
- Matthew J. Ferris
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 443-546-1300
-
Glen Burnie, Maryland, Forente stater, 21061
- Rekruttering
- UM Baltimore Washington Medical Center/Tate Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 410-553-8100
-
Hovedetterforsker:
- Matthew J. Ferris
-
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Massachusetts
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Boston, Massachusetts, Forente stater, 02111
- Rekruttering
- Tufts Medical Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 617-636-5000
- E-post: ContactUsCancerCenter@TuftsMedicalCenter.org
-
Hovedetterforsker:
- Francis W. Nugent
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48109
- Suspendert
- University of Michigan Rogel Cancer Center
-
Detroit, Michigan, Forente stater, 48201
- Aktiv, ikke rekrutterende
- Wayne State University/Karmanos Cancer Institute
-
Farmington Hills, Michigan, Forente stater, 48334
- Aktiv, ikke rekrutterende
- Weisberg Cancer Treatment Center
-
-
Minnesota
-
Bemidji, Minnesota, Forente stater, 56601
- Rekruttering
- Sanford Joe Lueken Cancer Center
-
Hovedetterforsker:
- Daniel Almquist
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 218-333-5000
- E-post: OncologyClinicalTrialsFargo@sanfordhealth.org
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-
Mississippi
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Jackson, Mississippi, Forente stater, 39216
- Suspendert
- University of Mississippi Medical Center
-
-
Missouri
-
Cape Girardeau, Missouri, Forente stater, 63703
- Suspendert
- Saint Francis Medical Center
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City of Saint Peters, Missouri, Forente stater, 63376
- Aktiv, ikke rekrutterende
- Siteman Cancer Center at Saint Peters Hospital
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Creve Coeur, Missouri, Forente stater, 63141
- Aktiv, ikke rekrutterende
- Siteman Cancer Center at West County Hospital
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Kansas City, Missouri, Forente stater, 64154
- Aktiv, ikke rekrutterende
- University of Kansas Cancer Center - North
-
Lee's Summit, Missouri, Forente stater, 64064
- Aktiv, ikke rekrutterende
- University of Kansas Cancer Center - Lee's Summit
-
North Kansas City, Missouri, Forente stater, 64116
- Aktiv, ikke rekrutterende
- University of Kansas Cancer Center at North Kansas City Hospital
-
Springfield, Missouri, Forente stater, 65804
- Suspendert
- Mercy Hospital Springfield
-
St Louis, Missouri, Forente stater, 63110
- Aktiv, ikke rekrutterende
- Washington University School of Medicine
-
St Louis, Missouri, Forente stater, 63128
- Rekruttering
- Mercy Hospital South
-
Hovedetterforsker:
- Jay W. Carlson
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 314-525-6042
- E-post: Danielle.Werle@mercy.net
-
St Louis, Missouri, Forente stater, 63141
- Rekruttering
- Mercy Hospital Saint Louis
-
Hovedetterforsker:
- Jay W. Carlson
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 314-251-7066
-
St Louis, Missouri, Forente stater, 63129
- Aktiv, ikke rekrutterende
- Siteman Cancer Center-South County
-
St Louis, Missouri, Forente stater, 63136
- Aktiv, ikke rekrutterende
- Siteman Cancer Center at Christian Hospital
-
-
Montana
-
Great Falls, Montana, Forente stater, 59405
- Rekruttering
- Benefis Sletten Cancer Institute
-
Hovedetterforsker:
- John M. Schallenkamp
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 406-969-6060
- E-post: mccinfo@mtcancer.org
-
Kalispell, Montana, Forente stater, 59901
- Rekruttering
- Logan Health Medical Center
-
Hovedetterforsker:
- John M. Schallenkamp
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 406-969-6060
- E-post: mccinfo@mtcancer.org
-
Missoula, Montana, Forente stater, 59804
- Rekruttering
- Community Medical Center
-
Hovedetterforsker:
- John M. Schallenkamp
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 406-969-6060
- E-post: mccinfo@mtcancer.org
-
-
Nebraska
-
Omaha, Nebraska, Forente stater, 68114
- Rekruttering
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 402-334-4773
-
Hovedetterforsker:
- Yungpo B. Su
-
Omaha, Nebraska, Forente stater, 68114
- Rekruttering
- Nebraska Methodist Hospital
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 402-354-5144
-
Hovedetterforsker:
- Yungpo B. Su
-
Omaha, Nebraska, Forente stater, 68114
- Suspendert
- Oncology Associates PC
-
-
New Jersey
-
Basking Ridge, New Jersey, Forente stater, 07920
- Aktiv, ikke rekrutterende
- Memorial Sloan Kettering Basking Ridge
-
Middletown, New Jersey, Forente stater, 07748
- Aktiv, ikke rekrutterende
- Memorial Sloan Kettering Monmouth
-
Montvale, New Jersey, Forente stater, 07645
- Aktiv, ikke rekrutterende
- Memorial Sloan Kettering Bergen
-
-
New Mexico
-
Albuquerque, New Mexico, Forente stater, 87106
- Aktiv, ikke rekrutterende
- University of New Mexico Cancer Center
-
-
New York
-
Commack, New York, Forente stater, 11725
- Aktiv, ikke rekrutterende
- Memorial Sloan Kettering Commack
-
Harrison, New York, Forente stater, 10604
- Aktiv, ikke rekrutterende
- Memorial Sloan Kettering Westchester
-
New York, New York, Forente stater, 10011
- Rekruttering
- Mount Sinai Chelsea
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 212-824-7309
- E-post: CCTO@mssm.edu
-
Hovedetterforsker:
- Richard L. Bakst
-
New York, New York, Forente stater, 10029
- Rekruttering
- Mount Sinai Hospital
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 212-824-7309
- E-post: CCTO@mssm.edu
-
Hovedetterforsker:
- Richard L. Bakst
-
New York, New York, Forente stater, 10065
- Aktiv, ikke rekrutterende
- Memorial Sloan Kettering Cancer Center
-
New York, New York, Forente stater, 10003
- Rekruttering
- Mount Sinai Union Square
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 212-824-7309
- E-post: CCTO@mssm.edu
-
Hovedetterforsker:
- Richard L. Bakst
-
Rochester, New York, Forente stater, 14642
- Rekruttering
- University of Rochester
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 585-275-5830
-
Hovedetterforsker:
- Monaliben Patel
-
Stony Brook, New York, Forente stater, 11794
- Rekruttering
- Stony Brook University Medical Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-862-2215
-
Hovedetterforsker:
- Amna Sher
-
The Bronx, New York, Forente stater, 10461
- Rekruttering
- Montefiore Medical Center-Einstein Campus
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 718-379-6866
- E-post: eskwak@montefiore.org
-
Hovedetterforsker:
- Rafi Kabarriti
-
The Bronx, New York, Forente stater, 10467
- Rekruttering
- Montefiore Medical Center - Moses Campus
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 718-379-6866
- E-post: eskwak@montefiore.org
-
Hovedetterforsker:
- Rafi Kabarriti
-
Uniondale, New York, Forente stater, 11553
- Aktiv, ikke rekrutterende
- Memorial Sloan Kettering Nassau
-
Webster, New York, Forente stater, 14580
- Rekruttering
- Wilmot Cancer Institute at Webster
-
Ta kontakt med:
- Site Public Contact
- E-post: WCICTOresearch@urmc.rochester.edu
-
Hovedetterforsker:
- Monaliben Patel
-
-
North Carolina
-
Asheboro, North Carolina, Forente stater, 27203
- Suspendert
- Randolph Hospital
-
Chapel Hill, North Carolina, Forente stater, 27599
- Rekruttering
- UNC Lineberger Comprehensive Cancer Center
-
Hovedetterforsker:
- Colette Shen
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 877-668-0683
- E-post: cancerclinicaltrials@med.unc.edu
-
Greensboro, North Carolina, Forente stater, 27403
- Rekruttering
- Cone Health Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 336-832-0836
- E-post: stacey.phelps@conehealth.com
-
Hovedetterforsker:
- Vinay K. Gudena
-
Reidsville, North Carolina, Forente stater, 27320
- Rekruttering
- Annie Penn Memorial Hospital
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 336-832-0836
- E-post: stacey.phelps@conehealth.com
-
Hovedetterforsker:
- Vinay K. Gudena
-
-
North Dakota
-
Bismarck, North Dakota, Forente stater, 58501
- Rekruttering
- Sanford Bismarck Medical Center
-
Hovedetterforsker:
- Daniel Almquist
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 701-323-5760
- E-post: OncologyClinicalTrialsFargo@sanfordhealth.org
-
Fargo, North Dakota, Forente stater, 58122
- Rekruttering
- Sanford Roger Maris Cancer Center
-
Hovedetterforsker:
- Daniel Almquist
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 701-234-6161
- E-post: OncologyClinicalTrialsFargo@sanfordhealth.org
-
-
Ohio
-
Beavercreek, Ohio, Forente stater, 45431
- Aktiv, ikke rekrutterende
- Indu and Raj Soin Medical Center
-
Centerville, Ohio, Forente stater, 45459
- Rekruttering
- Miami Valley Hospital South
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 937-528-2900
- E-post: clinical.trials@daytonncorp.org
-
Hovedetterforsker:
- Tarek M. Sabagh
-
Centerville, Ohio, Forente stater, 45459
- Aktiv, ikke rekrutterende
- Dayton Physicians LLC-Miami Valley South
-
Cleveland, Ohio, Forente stater, 44195
- Rekruttering
- Cleveland Clinic Foundation
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 866-223-8100
- E-post: TaussigResearch@ccf.org
-
Hovedetterforsker:
- Jessica L. Geiger
-
Dayton, Ohio, Forente stater, 45415
- Rekruttering
- Miami Valley Hospital North
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 937-528-2900
- E-post: clinical.trials@daytonncorp.org
-
Hovedetterforsker:
- Tarek M. Sabagh
-
Dayton, Ohio, Forente stater, 45409
- Rekruttering
- Premier Blood and Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 937-276-8320
-
Hovedetterforsker:
- Tarek M. Sabagh
-
Dayton, Ohio, Forente stater, 45415
- Aktiv, ikke rekrutterende
- Dayton Physician LLC - Englewood
-
Franklin, Ohio, Forente stater, 45005-1066
- Rekruttering
- Atrium Medical Center-Middletown Regional Hospital
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 937-528-2900
- E-post: clinical.trials@daytonncorp.org
-
Hovedetterforsker:
- Tarek M. Sabagh
-
Franklin, Ohio, Forente stater, 45005
- Aktiv, ikke rekrutterende
- Dayton Physicians LLC-Atrium
-
Greenville, Ohio, Forente stater, 45331
- Rekruttering
- Miami Valley Cancer Care and Infusion
-
Hovedetterforsker:
- Tarek M. Sabagh
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 937-569-7515
-
Kettering, Ohio, Forente stater, 45409
- Aktiv, ikke rekrutterende
- Greater Dayton Cancer Center
-
Kettering, Ohio, Forente stater, 45429
- Aktiv, ikke rekrutterende
- Kettering Medical Center
-
Troy, Ohio, Forente stater, 45373
- Rekruttering
- Upper Valley Medical Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 937-528-2900
- E-post: clinical.trials@daytonncorp.org
-
Hovedetterforsker:
- Tarek M. Sabagh
-
-
Oklahoma
-
Lawton, Oklahoma, Forente stater, 73505
- Rekruttering
- Cancer Centers of Southwest Oklahoma Research
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 877-231-4440
-
Hovedetterforsker:
- Minh Phan
-
Oklahoma City, Oklahoma, Forente stater, 73104
- Rekruttering
- University of Oklahoma Health Sciences Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 405-271-8777
- E-post: ou-clinical-trials@ouhsc.edu
-
Hovedetterforsker:
- Minh Phan
-
-
Oregon
-
Clackamas, Oregon, Forente stater, 97015
- Suspendert
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, Forente stater, 97015
- Suspendert
- Providence Cancer Institute Clackamas Clinic
-
Newberg, Oregon, Forente stater, 97132
- Rekruttering
- Providence Newberg Medical Center
-
Hovedetterforsker:
- Alison K. Conlin
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 503-215-2614
- E-post: CanRsrchStudies@providence.org
-
Portland, Oregon, Forente stater, 97213
- Rekruttering
- Providence Portland Medical Center
-
Hovedetterforsker:
- Alison K. Conlin
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 503-215-2614
- E-post: CanRsrchStudies@providence.org
-
Portland, Oregon, Forente stater, 97225
- Rekruttering
- Providence Saint Vincent Medical Center
-
Hovedetterforsker:
- Alison K. Conlin
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 503-215-2614
- E-post: CanRsrchStudies@providence.org
-
-
Pennsylvania
-
Altoona, Pennsylvania, Forente stater, 16601
- Rekruttering
- UPMC Altoona
-
Ta kontakt med:
- Site Public Contact
- E-post: ecog.rss@jimmy.harvard.edu
-
Hovedetterforsker:
- Dan P. Zandberg
-
Danville, Pennsylvania, Forente stater, 17822
- Rekruttering
- Geisinger Medical Center
-
Hovedetterforsker:
- Rajiv Panikkar
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 570-271-5251
- E-post: cancerresearch@geisinger.edu
-
Erie, Pennsylvania, Forente stater, 16505
- Rekruttering
- UPMC Hillman Cancer Center Erie
-
Hovedetterforsker:
- Dan P. Zandberg
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 412-864-7716
- E-post: ClinicalResearchServices@upmc.edu
-
Farrell, Pennsylvania, Forente stater, 16121
- Rekruttering
- UPMC Cancer Center at UPMC Horizon
-
Ta kontakt med:
- Site Public Contact
- E-post: ecog.rss@jimmy.harvard.edu
-
Hovedetterforsker:
- Dan P. Zandberg
-
Indiana, Pennsylvania, Forente stater, 15701
- Rekruttering
- IRMC Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 412-389-5208
- E-post: haneydl@upmc.edu
-
Hovedetterforsker:
- Dan P. Zandberg
-
Lewisburg, Pennsylvania, Forente stater, 17837
- Rekruttering
- Geisinger Medical Oncology-Lewisburg
-
Hovedetterforsker:
- Rajiv Panikkar
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 570-523-9200
- E-post: cancerresearch@geisinger.edu
-
New Castle, Pennsylvania, Forente stater, 16105
- Rekruttering
- UPMC Hillman Cancer Center - New Castle
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 412-389-5208
- E-post: haneydl@upmc.edu
-
Hovedetterforsker:
- Dan P. Zandberg
-
Philadelphia, Pennsylvania, Forente stater, 19107
- Rekruttering
- Thomas Jefferson University Hospital
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 215-600-9151
- E-post: ONCTrialNow@jefferson.edu
-
Hovedetterforsker:
- Jennifer M. Johnson
-
Philadelphia, Pennsylvania, Forente stater, 19111
- Rekruttering
- Fox Chase Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 215-728-4790
-
Hovedetterforsker:
- Thomas J. Galloway
-
Philadelphia, Pennsylvania, Forente stater, 19140
- Aktiv, ikke rekrutterende
- Temple University Hospital
-
Philadelphia, Pennsylvania, Forente stater, 19114
- Rekruttering
- Jefferson Torresdale Hospital
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 215-600-9151
- E-post: ONCTrialNow@jefferson.edu
-
Hovedetterforsker:
- Jennifer M. Johnson
-
Pittsburgh, Pennsylvania, Forente stater, 15232
- Aktiv, ikke rekrutterende
- UPMC-Shadyside Hospital
-
Pittsburgh, Pennsylvania, Forente stater, 15215
- Rekruttering
- UPMC-Saint Margaret
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 412-784-4900
-
Hovedetterforsker:
- Dan P. Zandberg
-
Pittsburgh, Pennsylvania, Forente stater, 15237
- Rekruttering
- UPMC-Passavant Hospital
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 412-367-6454
-
Hovedetterforsker:
- Dan P. Zandberg
-
Pittsburgh, Pennsylvania, Forente stater, 15232
- Rekruttering
- UPMC Hillman Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 412-647-8073
-
Hovedetterforsker:
- Dan P. Zandberg
-
Wilkes-Barre, Pennsylvania, Forente stater, 18711
- Rekruttering
- Geisinger Wyoming Valley/Henry Cancer Center
-
Hovedetterforsker:
- Rajiv Panikkar
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 570-271-5251
- E-post: HemonCCTrials@geisinger.edu
-
York, Pennsylvania, Forente stater, 17408
- Rekruttering
- UPMC Memorial
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 717-724-6760
-
Hovedetterforsker:
- Dan P. Zandberg
-
-
South Carolina
-
Charleston, South Carolina, Forente stater, 29425
- Rekruttering
- Medical University of South Carolina
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 843-792-9321
- E-post: hcc-clinical-trials@musc.edu
-
Hovedetterforsker:
- Jennifer L. Harper
-
-
South Dakota
-
Sioux Falls, South Dakota, Forente stater, 57117-5134
- Rekruttering
- Sanford USD Medical Center - Sioux Falls
-
Hovedetterforsker:
- Daniel Almquist
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 605-312-3320
- E-post: OncologyClinicalTrialsSF@SanfordHealth.org
-
Sioux Falls, South Dakota, Forente stater, 57105
- Rekruttering
- Avera Cancer Institute
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 605-322-3095
- E-post: OncRegulatory@avera.org
-
Hovedetterforsker:
- Benjamin M. Solomon
-
Yankton, South Dakota, Forente stater, 57078
- Rekruttering
- Avera Cancer Institute at Yankton
-
Hovedetterforsker:
- Benjamin M. Solomon
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 605-655-1800
- E-post: OncRegulatory@avera.org
-
-
Tennessee
-
Nashville, Tennessee, Forente stater, 37232
- Rekruttering
- Vanderbilt University/Ingram Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 800-811-8480
-
Hovedetterforsker:
- Jennifer H. Choe
-
-
Utah
-
Salt Lake City, Utah, Forente stater, 84112
- Aktiv, ikke rekrutterende
- Huntsman Cancer Institute/University of Utah
-
-
Virginia
-
Richmond, Virginia, Forente stater, 23235
- Rekruttering
- VCU Massey Cancer Center at Stony Point
-
Ta kontakt med:
- Site Public Contact
- E-post: ctoclinops@vcu.edu
-
Hovedetterforsker:
- Erin R. Alesi
-
Richmond, Virginia, Forente stater, 23298
- Rekruttering
- VCU Massey Comprehensive Cancer Center
-
Hovedetterforsker:
- Erin R. Alesi
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 804-628-6430
- E-post: CTOclinops@vcu.edu
-
-
Wisconsin
-
Antigo, Wisconsin, Forente stater, 54409
- Rekruttering
- Aspirus Cancer Care-Antigo-Volm Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 715-623-9869
- E-post: Juli.Alford@aspirus.org
-
Hovedetterforsker:
- Andrew J. Huang
-
Appleton, Wisconsin, Forente stater, 54911
- Rekruttering
- ThedaCare Regional Cancer Center
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 920-364-3604
- E-post: ResearchDept@thedacare.org
-
Hovedetterforsker:
- Matthias Weiss
-
Eau Claire, Wisconsin, Forente stater, 54701
- Aktiv, ikke rekrutterende
- HSHS Sacred Heart Hospital
-
Green Bay, Wisconsin, Forente stater, 54301
- Rekruttering
- Saint Vincent Hospital Cancer Center Green Bay
-
Hovedetterforsker:
- Brian L. Burnette
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 920-433-8889
- E-post: WI_research_admin@hshs.org
-
Green Bay, Wisconsin, Forente stater, 54303
- Rekruttering
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Hovedetterforsker:
- Brian L. Burnette
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 920-433-8889
- E-post: wi_research_admin@hshs.org
-
Menomonee Falls, Wisconsin, Forente stater, 53051
- Rekruttering
- Froedtert Menomonee Falls Hospital
-
Hovedetterforsker:
- Stuart J. Wong
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 262-257-5100
-
Milwaukee, Wisconsin, Forente stater, 53226
- Rekruttering
- Medical College of Wisconsin
-
Hovedetterforsker:
- Stuart J. Wong
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 414-805-3666
-
Oak Creek, Wisconsin, Forente stater, 53154
- Rekruttering
- Drexel Town Square Health Center
-
Hovedetterforsker:
- Stuart J. Wong
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 414-805-0505
-
Rhinelander, Wisconsin, Forente stater, 54501
- Rekruttering
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
-
Hovedetterforsker:
- Andrew J. Huang
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 715-847-2353
- E-post: Beth.Knetter@aspirus.org
-
Stevens Point, Wisconsin, Forente stater, 54481
- Rekruttering
- Aspirus Cancer Care - Stevens Point
-
Hovedetterforsker:
- Andrew J. Huang
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 715-847-2353
- E-post: Beth.Knetter@aspirus.org
-
Sturgeon Bay, Wisconsin, Forente stater, 54235-1495
- Rekruttering
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Hovedetterforsker:
- Brian L. Burnette
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 920-433-8889
- E-post: wi_research_admin@hshs.org
-
Wausau, Wisconsin, Forente stater, 54401
- Rekruttering
- Aspirus Cancer Care-Wausau
-
Hovedetterforsker:
- Andrew J. Huang
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 877-405-6866
-
West Bend, Wisconsin, Forente stater, 53095
- Rekruttering
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
Hovedetterforsker:
- Stuart J. Wong
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 414-805-0505
-
Wisconsin Rapids, Wisconsin, Forente stater, 54494
- Rekruttering
- Aspirus Cancer Care - Wisconsin Rapids
-
Hovedetterforsker:
- Andrew J. Huang
-
Ta kontakt med:
- Site Public Contact
- Telefonnummer: 715-422-7718
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
-
Patient must be between 18 and 79 years of age
-
Patient must have locoregionally recurrent or second primary HNSCC (oral cavity, oropharynx, larynx, hypopharynx) in a previously radiated field
-
Patient must have undergone surgery with gross total resection and must be randomized within 8 weeks of surgery
-
Patients must have high risk disease defined as:
-
Positive margins and/or extra nodal extension (ENE)
- Positive margins are defined as malignancy at or within 1 mm of the margin. High grade dysplasia (i.e. carcinoma in situ) at the margin is also considered positive
- ENE may be either gross or microscopic
-
-
Patient must have a PD-L1 Combined Positive Score (CPS) >= 1 in a Clinical Laboratory Improvement Act (CLIA) certified laboratory. Testing can be done locally as long as it is done in a CLIA certified laboratory. This testing must be on the tumor specimen from the resection of the patient's recurrent or second primary HNSCC
-
Patient must have had prior radiation to the area of recurrent or second primary tumor. This is defined as > 50% of the presurgical tumor volume having previously received a dose of > 45 Gy as determined by the treating radiation oncologist
-
Patient must have completed prior radiation a minimum of 6 months prior to randomization
-
Patient must not have any evidence of distant disease based on baseline imaging done within 28 days prior to randomization
-
Patient must not have received anti-PD-1/PD-L1 therapy for recurrent disease. If the patient received anti-PD-1/PD-L1 therapy as part of initial upfront curative intent treatment (either as part of definitive non-surgical therapy or in the adjuvant setting) in the past, the last dosage of anti-PD-1/PD-L1 therapy must have been given greater than one year prior to randomization
-
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
-
Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
-
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab or chemotherapy if the test done for eligibility/randomization is done outside of this 72 hour window. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A patient of childbearing potential is someone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
-
Patient must not expect to conceive or father children by using by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse while on study treatment, and continue for 120 days after the last dose of study treatment
-
Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 28 days prior to protocol randomization)
-
Platelets >= 100,000/mcL (obtained =< 28 days prior to protocol randomization)
-
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained =< 28 days prior to protocol randomization)
-
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3.0 x institutional ULN (obtained =< 28 days prior to protocol randomization)
-
Creatinine clearance > 30 ml/min using the Cockcroft-Gault formula (obtained =< 28 days prior to protocol randomization)
-
Patient must not have a current active infection that requires systemic treatment at time of randomization
-
Patient must not have a history of non-infectious pneumonitis requiring steroids within 3 years prior to randomization
-
Patient must not have a history of solid organ transplant or stem cell transplant
-
Patient must not be on immunosuppressive medication within 7 days prior to randomization, EXCEPT for the following: a) intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b) systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent; c) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
-
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional classification. Patients with New York Heart Association class III or IV heart failure are not eligible
-
Patient must not have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist [registered trademark]) are live attenuated vaccines and are not allowed
-
Patient must not have severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients
-
Patient must not have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
-
Patient must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
-
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial as long as they have not been HIV-infected with a history of Kaposi sarcoma and/or multicentric Castleman disease
-
Patient must not have a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection
- NOTE: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Arm B (cisplatin, carboplatin, IMRT, PBRT)
Patients receive cisplatin or carboplatin IV on day 1. Treatment repeats every 7 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo IMRT or PBRT QD for a total of 30 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the trial. |
Given IV
Andre navn:
Given IV
Andre navn:
Undergo CT
Andre navn:
Undergo MRI
Andre navn:
Undergo IMRT
Andre navn:
Undergo PBRT
Andre navn:
|
|
Eksperimentell: Arm C (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 6 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the trial. |
Undergo CT
Andre navn:
Undergo MRI
Andre navn:
Given IV
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival (OS)
Tidsramme: From randomization to date of death from any cause, measured at 2 years
|
Kaplan-Meier estimates will be used to estimate the OS distributions. A log-rank test with one-sided 10% type I error will be used for the comparison. |
From randomization to date of death from any cause, measured at 2 years
|
|
Incidence of adverse events
Tidsramme: Up to 5 years from date of registration
|
Assessed using Common Terminology Criteria for Adverse Events. An 80% confidence interval around the hazard ratio of the two experimental arms will be calculated. Toxicity will be compared between the two treatment arms. Toxicity will be examined by arm and compared using the Fisher's exact test. |
Up to 5 years from date of registration
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sykdomsfri overlevelse
Tidsramme: Fra datoen for randomisering til datoen for tilbakefall, andre primærtumor fra hode- og nakkeregionen, eller død, vurdert opp til 5 år fra registreringsdato
|
Fra datoen for randomisering til datoen for tilbakefall, andre primærtumor fra hode- og nakkeregionen, eller død, vurdert opp til 5 år fra registreringsdato
|
|
|
PD-L1 expression
Tidsramme: Up to 5 years from date of registration
|
Defined as Combined Positive Score >= 20 as a predictive marker of efficacy. |
Up to 5 years from date of registration
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Dan P Zandberg, ECOG-ACRIN Cancer Research Group
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Neoplasmer etter histologisk type
- Neoplasmer i hode og nakke
- Neoplasmer, kjertel og epitel
- Karsinom
- Karsinom, plateepitel
- Plateepitelkarsinom i hode og nakke
- Organiske kjemikalier
- Undersøkelsesteknikker
- Terapeutikk
- Fysiske fenomener
- Uorganiske kjemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinasjonskomplekser
- Elementer
- Metaller
- Kjemisteknikker, analytisk
- Spektrumanalyse
- Metaller, tunge
- Ioner
- Elektrolytter
- Platinumforbindelser
- Strålebehandling
- Overgangselementer
- Gasser
- Elementære partikler
- Strålebehandling, konform
- Strålebehandling, datamaskinassistert
- Tung ionstrålebehandling
- Kationer, monovalent
- Kationer
- Hydrogen
- Nukleoner
- Karboplatin
- Cisplatin
- 1,2-diaminocykloheksanplatina II sitrat
- pembrolizumab
- Magnetisk resonansspektroskopi
- Platinum
- Strålebehandling, intensitetsmodulert
- Protonterapi
- Protoner
Andre studie-ID-numre
- NCI-2020-13174
- U10CA180820 (U.S. NIH-stipend/kontrakt)
- NCI-2020-13174 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- EA3191 (Annen identifikator: CTEP)
- EA3191 (Annen identifikator: ECOG-ACRIN Cancer Research Group)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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