Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer

16. november 2015 opdateret af: Southwest Oncology Group

Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial With Molecular Correlates

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Spiserørskræft

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

Determine the 2-year overall survival of patients with previously untreated, clinically unresectable, locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus treated with cetuximab, cisplatin, irinotecan, and thoracic radiotherapy.

Secondary

Determine the toxicity profile of this regimen in these patients.
Determine the probability of objective response (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
Determine the time to progression in patients with measurable disease treated with this regimen.
Correlate, preliminarily, gene expression (RNA) levels and germline polymorphisms of genes involved in DNA repair (e.g., ECRCC-1 and XRCC-1), drug metabolism (e.g., UGT1A1), and the epidermal growth factor receptor (EGFR) pathway (e.g., EGFR, interleukin-8, and vascular endothelial growth factor) with response, time to progression, overall survival, and toxicity in patients treated with this regimen. (This will not be completed as this study was closed due to poor accrual.)

OUTLINE: This is a multicenter study.

Patients receive cetuximab intravenous (IV) over 1-2 hours on days 1, 8, and 15. Patients also receive cisplatin IV and irinotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of course 3, patients undergo thoracic radiotherapy once daily 5 days a week for 5-6 weeks (total of 28 treatments).

After completion of study treatment, patients are followed at 4 weeks and then every 3-6 months for up to 5 years after study entry.

PROJECTED ACCRUAL: A total of 75-100 patients (75 with adenocarcinoma and 25 with squamous cell carcinoma) will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alabama
  - Mobile, Alabama, Forenede Stater, 36652-2144
    - Mobile Infirmary Medical Center
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- California
  - Berkeley, California, Forenede Stater, 94704
    - Alta Bates Comprehensive Cancer Center
  - Burbank, California, Forenede Stater, 91505
    - Providence Saint Joseph Medical Center - Burbank
  - Burlingame, California, Forenede Stater, 94010
    - Peninsula Medical Center
  - Castro Valley, California, Forenede Stater, 94546
    - Eden Medical Center
  - Greenbrae, California, Forenede Stater, 94904
    - Marin Cancer Institute at Marin General Hospital
  - Greenbrae, California, Forenede Stater, 94904
    - Sutter Health - Western Division Cancer Research Group
  - Hayward, California, Forenede Stater, 94545
    - Saint Rose Hospital
  - Los Angeles, California, Forenede Stater, 90089-9181
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Oakland, California, Forenede Stater, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, Forenede Stater, 94602
    - Highland General Hospital
  - Oakland, California, Forenede Stater, 94609
    - CCOP - Bay Area Tumor Institute
  - Palm Springs, California, Forenede Stater, 92262
    - Desert Regional Medical Center Comprehensive Cancer Center
  - Pleasanton, California, Forenede Stater, 94588
    - Valley Care Medical Center
  - Sacramento, California, Forenede Stater, 95817
    - University of California Davis Cancer Center
  - San Francisco, California, Forenede Stater, 94118
    - California Pacific Medical Center - California Campus
  - San Pablo, California, Forenede Stater, 94806
    - Doctors Medical Center - San Pablo Campus
  - Sana Rosa, California, Forenede Stater, 95405
    - CCOP - Santa Rosa Memorial Hospital
  - Vallejo, California, Forenede Stater, 94589
    - Sutter Solano Medical Center
- Colorado
  - Fort Collins, Colorado, Forenede Stater, 80524
    - Poudre Valley Hospital
- Florida
  - Lakeland, Florida, Forenede Stater, 33804-5000
    - Watson Clinic, LLC
- Georgia
  - Augusta, Georgia, Forenede Stater, 30901
    - Augusta Oncology Associates - Walton Way
  - Savannah, Georgia, Forenede Stater, 31403-3089
    - Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  - Savannah, Georgia, Forenede Stater, 31405
    - Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- Idaho
  - Boise, Idaho, Forenede Stater, 83712
    - St. Luke's Mountain States Tumor Institute - Boise
- Illinois
  - Springfield, Illinois, Forenede Stater, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
- Indiana
  - Beech Grove, Indiana, Forenede Stater, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Richmond, Indiana, Forenede Stater, 47374
    - Reid Hospital & Health Care Services, Incorporated
- Kansas
  - Chanute, Kansas, Forenede Stater, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, Forenede Stater, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, Forenede Stater, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Kansas City, Kansas, Forenede Stater, 66160-7357
    - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  - Kingman, Kansas, Forenede Stater, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Liberal, Kansas, Forenede Stater, 67901
    - Southwest Medical Center
  - Newton, Kansas, Forenede Stater, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, Forenede Stater, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, Forenede Stater, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, Forenede Stater, 67042
    - Cancer Center of Kansas, PA - Salina
  - Salina, Kansas, Forenede Stater, 67401
    - Tammy Walker Cancer Center at Salina Regional Health Center
  - Wellington, Kansas, Forenede Stater, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, Forenede Stater, 67214
    - Wesley Medical Center
  - Wichita, Kansas, Forenede Stater, 67203
    - Associates in Womens Health, PA - North Review
  - Wichita, Kansas, Forenede Stater, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, Forenede Stater, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, Forenede Stater, 67214
    - CCOP - Wichita
  - Wichita, Kansas, Forenede Stater, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Winfield, Kansas, Forenede Stater, 67156
    - Cancer Center of Kansas, PA - Winfield
- Kentucky
  - Lexington, Kentucky, Forenede Stater, 40536-0293
    - Markey Cancer Center at University of Kentucky Chandler Medical Center
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48109-0942
    - University of Michigan Comprehensive Cancer Center
  - Battle Creek, Michigan, Forenede Stater, 49017
    - Battle Creek Health System Cancer Care Center
  - Big Rapids, Michigan, Forenede Stater, 49307
    - Mecosta County Medical Center
  - Detroit, Michigan, Forenede Stater, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Lacks Cancer Center at Saint Mary's Health Care
  - Grand Rapids, Michigan, Forenede Stater, 49506
    - Metro Health Hospital
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Spectrum Health Hospital - Butterworth Campus
  - Holland, Michigan, Forenede Stater, 49423
    - Holland Community Hospital
  - Muskegon, Michigan, Forenede Stater, 49442
    - Hackley Hospital
  - Traverse City, Michigan, Forenede Stater, 49684
    - Munson Medical Center
- Missouri
  - Kansas City, Missouri, Forenede Stater, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Forenede Stater, 63110
    - Saint Louis University Cancer Center
  - Springfield, Missouri, Forenede Stater, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, Forenede Stater, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, Forenede Stater, 65807
    - Hulston Cancer Center at Cox Medical Center South
- Montana
  - Billings, Montana, Forenede Stater, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, Forenede Stater, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, Forenede Stater, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, Forenede Stater, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, Forenede Stater, 59107-7000
    - Billings Clinic - Downtown
  - Bozeman, Montana, Forenede Stater, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, Forenede Stater, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, Forenede Stater, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, Forenede Stater, 59405
  - Helena, Montana, Forenede Stater, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, Forenede Stater, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, Forenede Stater, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, Forenede Stater, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, Forenede Stater, 59801
    - Community Medical Center
  - Missoula, Montana, Forenede Stater, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, Forenede Stater, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, Forenede Stater, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Kearney, Nebraska, Forenede Stater, 68848-1990
    - Good Samaritan Cancer Center at Good Samaritan Hospital
- New York
  - Rochester, New York, Forenede Stater, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
  - Rochester, New York, Forenede Stater, 14623
    - Interlakes Oncology/Hematology PC
- North Carolina
  - Goldsboro, North Carolina, Forenede Stater, 27534
    - Wayne Memorial Hospital, Incorporated
- Ohio
  - Akron, Ohio, Forenede Stater, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Dayton, Ohio, Forenede Stater, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, Forenede Stater, 45405
    - Grandview Hospital
  - Dayton, Ohio, Forenede Stater, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, Forenede Stater, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, Forenede Stater, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, Forenede Stater, 45429
    - CCOP - Dayton
  - Findlay, Ohio, Forenede Stater, 45840
    - Blanchard Valley Medical Associates
  - Kettering, Ohio, Forenede Stater, 45429
    - Charles F. Kettering Memorial Hospital
  - Middletown, Ohio, Forenede Stater, 45044
    - Middletown Regional Hospital
  - Troy, Ohio, Forenede Stater, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Xenia, Ohio, Forenede Stater, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Oregon
  - Gresham, Oregon, Forenede Stater, 97030
    - Legacy Mount Hood Medical Center
  - Milwaukie, Oregon, Forenede Stater, 97222
    - Providence Milwaukie Hospital
  - Portland, Oregon, Forenede Stater, 97227
    - Northwest Cancer Specialists at Rose Quarter Cancer Center
  - Portland, Oregon, Forenede Stater, 97213-2967
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, Forenede Stater, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, Forenede Stater, 97225
    - Providence St. Vincent Medical Center
  - Portland, Oregon, Forenede Stater, 97210
    - Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
  - Portland, Oregon, Forenede Stater, 97227
    - Legacy Emanuel Hospital and Health Center & Children's Hospital
  - Portland, Oregon, Forenede Stater, 97239-3098
    - Oregon Health & Science University Cancer Institute
  - Salem, Oregon, Forenede Stater, 97309-5014
    - Salem Hospital Regional Cancer Care Services
  - Tualatin, Oregon, Forenede Stater, 97062
    - Legacy Meridian Park Hospital
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Charleston, South Carolina, Forenede Stater, 29401
    - Roper St. Francis Cancer Center at Roper Hospital
  - Greenville, South Carolina, Forenede Stater, 29615
    - CCOP - Greenville
- Tennessee
  - Kingsport, Tennessee, Forenede Stater, 37662
    - Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
  - Knoxville, Tennessee, Forenede Stater, 37920-6999
    - U.T. Cancer Institute at University of Tennessee Medical Center
- Virginia
  - Danville, Virginia, Forenede Stater, 24541
    - Danville Regional Medical Center
  - Norton, Virginia, Forenede Stater, 24273
    - Southwest Virginia Regional Cancer Center
- Washington
  - Bellingham, Washington, Forenede Stater, 98225
    - St. Joseph Cancer Center
  - Bremerton, Washington, Forenede Stater, 98310
    - Olympic Hematology and Oncology
  - Kennewick, Washington, Forenede Stater, 99336
    - Columbia Basin Hematology
  - Mt. Vernon, Washington, Forenede Stater, 98273
    - Skagit Valley Hospital Cancer Care Center
  - Seattle, Washington, Forenede Stater, 98104
    - Harborview Medical Center
  - Seattle, Washington, Forenede Stater, 98104
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, Forenede Stater, 98104
    - Minor and James Medical, PLLC
  - Seattle, Washington, Forenede Stater, 98112
    - Group Health Central Hospital
  - Seattle, Washington, Forenede Stater, 98122-4307
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Seattle, Washington, Forenede Stater, 98122
    - Polyclinic First Hill
  - Seattle, Washington, Forenede Stater, 98195-6043
    - University Cancer Center at University of Washington Medical Center
  - Spokane, Washington, Forenede Stater, 99202
    - Cancer Care Northwest - Spokane South
  - Vancouver, Washington, Forenede Stater, 98684
    - Northwest Cancer Specialists at Vancouver Cancer Center
  - Vancouver, Washington, Forenede Stater, 98668
    - Southwest Washington Medical Center Cancer Center
  - Wenatchee, Washington, Forenede Stater, 98801-2028
    - Wenatchee Valley Medical Center
- Wyoming
  - Sheridan, Wyoming, Forenede Stater, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (≥ 20 cm from the incisors*) or the gastroesophageal junction (confined to ≤ 2 cm into the gastric cardia)
- Disease confined to the esophagus or peri-esophageal soft tissue
- T4, M0 disease
- Surgically unresectable disease by esophageal endoscopic ultrasonography OR medically unresectable disease

NOTE: *Patients with primary disease < 26 cm from the incisors must undergo bronchoscopy AND have negative cytology within the past 4 weeks

Measurable or non-measurable disease by x-ray, CT scan and/or MRI, or physical examination within the past 4 weeks (for measurable disease) or within the past 6 weeks (for non-measurable disease)
Tumor specimens available
No recurrent disease

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count (ANC) ≥ 1,500/mm^3
White Blood Cell (WBC) count ≥ 3,000/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10.0 g/dL

Hepatic

Albumin normal
Bilirubin normal
Alkaline phosphatase normal
Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times upper limit of normal

Renal

Creatinine clearance > 50 mL/min

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No prior severe reaction to monoclonal antibodies
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy for esophageal cancer

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy for esophageal cancer
No concurrent intensity modulated radiotherapy
No concurrent cobalt-60

Surgery

No prior surgical resection or attempted surgical resection of esophageal cancer

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: N/A
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Treatment Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3.	Biologisk: cetuximab 400mg/m^2 loading dose, intravenous (IV) over 120 min, day 1 of cycle 1 only. 250mg/m^2 maintenance dose, IV over 60 min, Days 8 & 15 of Cycle 1 and Days 1, 8, and 15 of subsequent cycles. Andre navne: Erbitux Medicin: cisplatin 30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle. Andre navne: Platinol Medicin: irinotecan hydrochloride 65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle. Andre navne: CPT-11 Stråling: radiation therapy The total dose to the prescription point will be 5,040 cGy given in 28 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter. The dose variation in the planning target volume (PTV) will be +7% and -5% of the prescription point dose. Andre navne: RT TRT

Deltagergruppe / Arm

Intervention / Behandling

Eksperimentel: Treatment

Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3.

Biologisk: cetuximab

400mg/m^2 loading dose, intravenous (IV) over 120 min, day 1 of cycle 1 only. 250mg/m^2 maintenance dose, IV over 60 min, Days 8 & 15 of Cycle 1 and Days 1, 8, and 15 of subsequent cycles.

Andre navne:

Erbitux

Medicin: cisplatin

30mg/m^2, bolus intravenous (IV), on Days 1 & 8 of each cycle.

Andre navne:

Platinol

Medicin: irinotecan hydrochloride

65mg/m^2, intravenous (IV) over 30 min, on Days 1 & 8 of each cycle.

Andre navne:

CPT-11

Stråling: radiation therapy

The total dose to the prescription point will be 5,040 cGy given in 28 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter. The dose variation in the planning target volume (PTV) will be +7% and -5% of the prescription point dose.

Andre navne:

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Overall Survival at 2 Years Tidsramme: 0-2 years	Measured from time of registration to date of death due to any cause, or last contact date	0-2 years

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Tidsramme: Patients were assessed for adverse events after every two cycles of chemotherapy.	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.	Patients were assessed for adverse events after every two cycles of chemotherapy.
Objective Response (Confirmed and Unconfined, Complete and Partial) Tidsramme: at week 16, then every 3 months until progression	Complete response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.	at week 16, then every 3 months until progression
Progression Free Survival Tidsramme: 0 - 5 years	Measured from date of registration to date of first observation of progression or symptomatic deterioration. Patients last known to be alive and progression-free are censored at date of last contact.	0 - 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southwest Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

Studiestol: Lisa Hammond, MD, The University of Texas Health Science Center at San Antonio
Studiestol: Charles R. Thomas, MD, OHSU Knight Cancer Institute
Studiestol: Charles D. Blanke, MD, FACP, OHSU Knight Cancer Institute
Studiestol: Vivek Mehta, MD, Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2005

Primær færdiggørelse (Faktiske)

1. september 2009

Studieafslutning (Faktiske)

1. maj 2012

Datoer for studieregistrering

Først indsendt

3. maj 2005

Først indsendt, der opfyldte QC-kriterier

3. maj 2005

Først opslået (Skøn)

4. maj 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. november 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CDR0000426442
U10CA032102 (U.S. NIH-bevilling/kontrakt)
S0414 (Anden identifikator: SWOG)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Spiserørskræft

Assiut University

Ikke rekrutterer endnu

Komparativ undersøgelse af peroral endoskopisk myotomi (POEM) i behandling - naïve achalasi-patienter versus patienter med tidligere pneumatisk dilation

Achalasia, esophageal
The Methodist Hospital Research Institute

Afsluttet

Et forsøg med esophageal og gastrisk stenting for lækage eller perforering (ESO-stent)

Esophageal eller gastrisk perforering | Esophageal eller gastrisk lækage

Forenede Stater
Federal University of São Paulo

Ukendt

Evaluering af topisk mitomycin C som adjuverende lægemiddel til esophageal dilatation hos børn

Esophageal forsnævring | Ætsende esophageal forsnævring | Peptisk esophageal forsnævring | Post-kirurgisk esophageal striktur

Brasilien
Johns Hopkins University

Trukket tilbage

Esophageal stentmigrering med endoskopisk suturfiksering sammenlignet med standardinstallation

Esophageal Perforation | Esophageal fistel | Forsnævring af spiserøret | Esophageal lækage | Endostitch | Esophageal stent

Forenede Stater
Mayo Clinic
National Cancer Institute (NCI)

Afsluttet

Karakterisering af kemo-radioterapi behandlingsrelaterede hjerteforandringer hos ikke-metastaserende, ikke-tilbagevendende lunge- og spiserørskræftpatienter

Stadie III lungekræft AJCC v8 | Stadie II lungekræft AJCC v8 | Stadie IIA lungekræft AJCC v8 | Stadie IIB lungekræft AJCC v8 | Stadie IIIA Lungekræft AJCC v8 | Stadie IIIB Lungekræft AJCC v8 | Stadie I lungekræft AJCC v8 | Stadie IA1 Lungekræft AJCC v8 | Stadie IA2 Lungekræft AJCC v8 | Stadie IA3 lungekræft... og andre forhold

Forenede Stater
Boston Children's Hospital
Children's Hospital of Philadelphia

Rekruttering

Balloninflationstid for esophageal strenge (bid): En randomiseret multicenterundersøgelse (BITES)

Esophageal atresi | Forsnævring af spiserøret | Esophageal atresi med tracheo-esophageal fistel

Forenede Stater
Shaare Zedek Medical Center
European Society of Pediatric Gastroenterology, Hepatology and Nutrition

Ikke rekrutterer endnu

Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.

Esophageal forsnævring

Israel
UMC Utrecht
Julius Centre for Health Sciences and Primary Care, UMC Utrecht

Rekruttering

Kombination af kemoterapi og adaptiv MR-vejledt strålebehandling for at forbedre resultater hos patienter med adenokarcinom i spiserøret (MERGE)

Esophageal Adenocarcinom | Esophageal Adenocarcinom (EAC) | Adenocarcinom - Gastroøsofageal Junction (GEJ)

Holland
Case Comprehensive Cancer Center
National Cancer Institute (NCI)

Afsluttet

Molekylær fænotypning til forudsigelse af respons hos patienter med trin IB-III spiserørskræft, der modtager kombinationskemoterapi

Stadium IIIA Esophageal Adenocarcinom | Stadium IIIB Esophageal Adenocarcinom | Stadie IIIC Esophageal Adenocarcinom | Stadium IIB Esophageal Adenocarcinom | Stadium IB Esophageal Adenocarcinom | Stadie IIA Esophageal Adenocarcinom

Forenede Stater
Federico II University

Rekruttering

Brug af indocyaningrøn fluorescens (ICG) under laparoskopisk Hellerdor

Achalasia | Indocyanin grøn | Indocyanin grøn (ICG) | Achalasia, esophageal

Italien

Kliniske forsøg med cetuximab

University Medical Center Groningen
UMC Utrecht; Erasmus Medical Center

Rekruttering

Billedstyret kirurgi til marginvurdering af hoved- og nakkekræft ved hjælp af Cetuximab-IRDye800CW conjugate (ICON)

Planocellulært karcinom i hoved og hals | Marginvurdering

Holland
Amsterdam UMC, location VUmc
Radboud University Medical Center; University Medical Center Groningen

Afsluttet

Billedstyret behandlingsoptimering med Cetuximab til patienter med metastatisk tyktarmskræft (IMPACT-CRC)

Metastatisk tyktarmskræft

Holland
Shanghai Ninth People's Hospital Affiliated to...

Rekruttering

Dalpicilib plus cetuximab sammenlignet med cetuximab alene i HPV-negativ, anti-PD-1-resistent R/M HNSCC

Tilbagevendende/metastatisk pladecellekræft i hoved og hals

Kina
Zhejiang University

Rekruttering

Sikkerhed og effekt af Cetuximab Beta plus Fruquintinib med eller uden immun checkpoint-hæmmere i første-linje behandling af RAS/BRAF wild type uoperabel metastatisk tyktarmskræft (concept)

Kolorektale neoplasmer | Fruquintinib | BRAF | RAS | Cetuximabβ

Kina
Meng Qiu

Ikke rekrutterer endnu

Førstelinjebehandling af MCapOX + Cetuximab vs. MFOLFOX6 + Cetuximab til RAS/BRAF vildtype, MSS, uoperabel venstresidet MCRC: et multicenter, randomiseret, kontrolleret, fase III-studie (CAPCET-III)

Capecitabin | Kolorektal cancer (CRC) | Cetuximab

Kina
West China Hospital
First Affiliated Hospital of Chongqing Medical University

Rekruttering

Førstelinje mCapOX+Cetuximab vs. mFOLFOX6+Cetuximab til metastatisk venstresidet CRC med vildtype RAS/BRAF-gener (CAPCET)

Colo-rektal cancer | Capecitabin | Cetuximab

Kina
Eben Rosenthal
National Cancer Institute (NCI)

Afsluttet

Cetuximab-IRDye 800CW og intraoperativ billeddannelse til at finde kræft i bugspytkirtlen hos patienter, der gennemgår kirurgi

Adenocarcinom i bugspytkirtlen

Forenede Stater
HiberCell, Inc.

Afsluttet

Undersøgelse af Imprime PGG® i kombination med Cetuximab hos forsøgspersoner med tilbagevendende eller progressiv KRAS vildtype kolorektal cancer (PRIMUS)

Kolorektal cancer

Forenede Stater, Puerto Rico, Tyskland, Frankrig
Merck KGaA, Darmstadt, Germany

Afsluttet

Undersøgelse for at evaluere effektiviteten og sikkerheden af FOLFOX-4 Plus Cetuximab versus UFOX Plus Cetuximab. (FUTURE)

Tidligere ubehandlet metastatisk tyktarmskræft

Frankrig, Italien, Polen, Tyskland, Hong Kong, Østrig, Brasilien, Israel, Grækenland, Argentina, Thailand, Belgien, Australien, Mexico
Arbeitsgemeinschaft medikamentoese Tumortherapie
Merck Sharp & Dohme LLC

Afsluttet

Biomarkør-rettet behandling ved metastatisk kolorektal cancer

Metastatisk tyktarmskræft

Østrig

S0414 Cetuximab, Combo Chemo, and RT in Locally Advanced Esophageal Cancer

Cetuximab Plus Cisplatin, Irinotecan and Thoracic Radiotherapy (TRT) for Locally Advanced (Non-Metastatic), Clinically Unresectable Esophageal Cancer: A Phase II Trial With Molecular Correlates

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Spiserørskræft

Kliniske forsøg med cetuximab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer