- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00860041
Acute Pain Caused by Paclitaxel in Patients With Cancer
Paclitaxel-Associated Acute Pain Syndrome Natural History Study
RATIONALE: Gathering information over time from patients receiving paclitaxel for cancer may help doctors learn more about pain caused by paclitaxel and plan the best treatment.
PURPOSE: This clinical trial is studying acute pain caused by paclitaxel in patients with cancer.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
OBJECTIVES:
- To describe the incidence and characteristics of and change in pain related to paclitaxel infusions over several courses in patients receiving paclitaxel weekly or every 2-4 weeks with or without neurotoxic chemotherapy.
- To investigate the association between paclitaxel-induced acute pain syndrome symptoms and eventual chemotherapy-induced neuropathy.
- To perform exome-sequencing analysis and identify genetic variants that predict paclitaxel- induced peripheral neuropathy.
- To identify clinical phenotypes associated with paclitaxel toxicity (i.e., acute pain syndrome and neuropathy).
- To explore whether there are any evident differences between results seen in the majority Caucasian population and the minority populations.
OUTLINE: This is a multicenter study. Patients are grouped according to paclitaxel dosing schedule (weekly vs every 2-4 weeks) and concurrent use of neurotoxic agent (yes vs no).
Blood samples are collected at baseline for correlative laboratory studies, including genetic biomarker and polymorphism studies.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Colorado
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Aurora, Colorado, Spojené státy, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Spojené státy, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Spojené státy, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Spojené státy, 80210
- Porter Adventist Hospital
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Denver, Colorado, Spojené státy, 80220
- Rose Medical Center
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Denver, Colorado, Spojené státy, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Spojené státy, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Spojené státy, 80218
- St. Joseph Hospital
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Denver, Colorado, Spojené státy, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Spojené státy, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Spojené státy, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Spojené státy, 80631
- North Colorado Medical Center
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Littleton, Colorado, Spojené státy, 80122
- Littleton Adventist Hospital
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Lone Tree, Colorado, Spojené státy, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Spojené státy, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Spojené státy, 80539
- McKee Medical Center
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Parker, Colorado, Spojené státy, 80138
- Parker Adventist Hospital
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Pueblo, Colorado, Spojené státy, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Spojené státy, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Spojené státy, 80033
- Exempla Lutheran Medical Center
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Connecticut
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Hartford, Connecticut, Spojené státy, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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Hawaii
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Aiea, Hawaii, Spojené státy, 96701
- Kapiolani Medical Center at Pali Momi
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Honolulu, Hawaii, Spojené státy, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Spojené státy, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Spojené státy, 96813
- OnCare Hawaii, Incorporated - Lusitana
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Honolulu, Hawaii, Spojené státy, 96813
- Queen's Cancer Institute at Queen's Medical Center
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Honolulu, Hawaii, Spojené státy, 96813
- Straub Clinic and Hospital, Incorporated
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Honolulu, Hawaii, Spojené státy, 96817
- Hawaii Medical Center - East
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Honolulu, Hawaii, Spojené státy, 96817
- OnCare Hawaii, Incorporated - Kuakini
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Honolulu, Hawaii, Spojené státy, 96859
- Tripler Army Medical Center
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Lihue, Hawaii, Spojené státy, 96766
- Kauai Medical Clinic
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Wailuku, Hawaii, Spojené státy, 96793
- Maui Memorial Medical Center
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Wailuku, Hawaii, Spojené státy, 96793
- Pacific Cancer Institute - Maui
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Idaho
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Boise, Idaho, Spojené státy, 83706
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
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Illinois
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Bloomington, Illinois, Spojené státy, 61701
- St. Joseph Medical Center
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Bloomington%, Illinois, Spojené státy, 61701
- Illinois CancerCare - Bloomington
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Canton, Illinois, Spojené státy, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Spojené státy, 61520
- Graham Hospital
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Carthage, Illinois, Spojené státy, 62321
- Memorial Hospital
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Carthage, Illinois, Spojené státy, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Spojené státy, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Spojené státy, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Spojené státy, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, Spojené státy, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Spojené státy, 62644
- Mason District Hospital
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Havana, Illinois, Spojené státy, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Spojené státy, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Spojené státy, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Spojené státy, 61455
- Mcdonough District Hospital
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Moline, Illinois, Spojené státy, 61265
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Moline, Illinois, Spojené státy, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Spojené státy, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, Spojené státy, 61462
- OSF Holy Family Medical Center
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Normal, Illinois, Spojené státy, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Spojené státy, 61761
- Community Cancer Center
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Normal, Illinois, Spojené státy, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Spojené státy, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Spojené státy, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Spojené státy, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Spojené státy, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Spojené státy, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Spojené státy, 61614
- Proctor Hospital
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Peoria, Illinois, Spojené státy, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Spojené státy, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Spojené státy, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Spojené státy, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Spojené státy, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Spojené státy, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Spojené státy, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Spojené státy, 61362
- Illinois CancerCare - Spring Valley
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Indiana
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Elkhart, Indiana, Spojené státy, 46515
- Elkhart General Hospital
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Elkhart, Indiana, Spojené státy, 46514
- Michiana Hematology-Oncology, PC - Elkhart
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Kokomo, Indiana, Spojené státy, 46904
- Howard Community Hospital
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La Porte, Indiana, Spojené státy, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, Spojené státy, 46545-1470
- Michiana Hematology-Oncology, PC - South Bend
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Mishawaka, Indiana, Spojené státy, 46545-1470
- Saint Joseph Regional Medical Center
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Plymouth, Indiana, Spojené státy, 46563
- Michiana Hematology Oncology PC - Plymouth
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South Bend, Indiana, Spojené státy, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Spojené státy, 46601
- CCOP - Northern Indiana CR Consortium
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Westville, Indiana, Spojené státy, 46391
- Michiana Hematology Oncology PC - La Porte
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Iowa
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Ames, Iowa, Spojené státy, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, Spojené státy, 52722
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Cedar Rapids, Iowa, Spojené státy, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Spojené státy, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Clive, Iowa, Spojené státy, 50325
- Medical Oncology and Hematology Associates - West Des Moines
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Des Moines, Iowa, Spojené státy, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Spojené státy, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Spojené státy, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Spojené státy, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Spojené státy, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Spojené státy, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Mason City, Iowa, Spojené státy, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, Spojené státy, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, Spojené státy, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Spojené státy, 51102
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, Spojené státy, 51104
- St. Luke's Regional Medical Center
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Kansas
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Chanute, Kansas, Spojené státy, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Spojené státy, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Spojené státy, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Spojené státy, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Spojené státy, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Spojené státy, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Spojené státy, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Spojené státy, 67901
- Cancer Center of Kansas, PA - Liberal
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McPherson, Kansas, Spojené státy, 67460
- Cancer Center of Kansas, PA - McPherson
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Newton, Kansas, Spojené státy, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Spojené státy, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Spojené státy, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Spojené státy, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Spojené státy, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Spojené státy, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Spojené státy, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Spojené státy, 67214
- CCOP - Wichita
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Wichita, Kansas, Spojené státy, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Spojené státy, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Spojené státy, 67156
- Cancer Center of Kansas, PA - Winfield
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Louisiana
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Baton Rouge, Louisiana, Spojené státy, 70809
- Ochsner Health Center - Bluebonnet
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New Orleans, Louisiana, Spojené státy, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Spojené státy, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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Michigan
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Adrian, Michigan, Spojené státy, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Spojené státy, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Spojené státy, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Spojené státy, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Spojené státy, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, Spojené státy, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Spojené státy, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Spojené státy, 48503
- Hurley Medical Center
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Flint, Michigan, Spojené státy, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Spojené státy, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Spojené státy, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Spojené státy, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, Spojené státy, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Spojené státy, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Spojené státy, 49201
- Foote Memorial Hospital
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Lansing, Michigan, Spojené státy, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Spojené státy, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, Spojené státy, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Spojené státy, 48162
- Mercy Memorial Hospital - Monroe
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Muskegon, Michigan, Spojené státy, 49443
- Mercy General Health Partners
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Pontiac, Michigan, Spojené státy, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Spojené státy, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Spojené státy, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Saint Joseph, Michigan, Spojené státy, 49085
- Lakeside Cancer Specialists, PLLC
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St. Joseph, Michigan, Spojené státy, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Traverse City, Michigan, Spojené státy, 49684
- Munson Medical Center
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Warren, Michigan, Spojené státy, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, Spojené státy, 56308
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Bemidji, Minnesota, Spojené státy, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Spojené státy, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Spojené státy, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Spojené státy, 55805
- CCOP - Duluth
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Duluth, Minnesota, Spojené státy, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Spojené státy, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Spojené státy, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Spojené státy, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Spojené státy, 55350
- Hutchinson Area Health Care
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Mankato, Minnesota, Spojené státy, 56002
- Immanuel St. Joseph's
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Maplewood, Minnesota, Spojené státy, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, Spojené státy, 55109
- Minnesota Oncology - Maplewood
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Minneapolis, Minnesota, Spojené státy, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Spojené státy, 55415
- Hennepin County Medical Center - Minneapolis
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New Ulm, Minnesota, Spojené státy, 56073
- New Ulm Medical Center
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Robbinsdale, Minnesota, Spojené státy, 55422-2900
- Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Spojené státy, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Spojené státy, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Spojené státy, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Spojené státy, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Spojené státy, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Spojené státy, 55102
- United Hospital
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Shakopee, Minnesota, Spojené státy, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St. Paul, Minnesota, Spojené státy, 55101
- Regions Hospital Cancer Care Center
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Stillwater, Minnesota, Spojené státy, 55082
- Lakeview Hospital
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Waconia, Minnesota, Spojené státy, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Spojené státy, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, Spojené státy, 55125
- Minnesota Oncology - Woodbury
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Missouri
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Cape Girardeau, Missouri, Spojené státy, 63703
- Southeast Cancer Center
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Jefferson City, Missouri, Spojené státy, 65109
- Goldschmidt Cancer Center
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Saint Louis, Missouri, Spojené státy, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, Spojené státy, 63141
- Comprehensive Cancer Care, PC
-
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Montana
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Billings, Montana, Spojené státy, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Spojené státy, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Spojené státy, 59107-7000
- Billings Clinic - Downtown
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Billings, Montana, Spojené státy, 59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Bozeman, Montana, Spojené státy, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Spojené státy, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Spojené státy, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Spojené státy, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Havre, Montana, Spojené státy, 59501
- Northern Montana Hospital
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Helena, Montana, Spojené státy, 59601
- St. Peter's Hospital
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Kalispell, Montana, Spojené státy, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, Spojené státy, 59901
- Glacier Oncology, PLLC
-
Kalispell, Montana, Spojené státy, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Spojené státy, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Spojené státy, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Lincoln, Nebraska, Spojené státy, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Spojené státy, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Spojené státy, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, Spojené státy, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
-
Omaha, Nebraska, Spojené státy, 68131-2197
- Creighton University Medical Center
-
Omaha, Nebraska, Spojené státy, 68130
- Lakeside Hospital
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North Dakota
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Bismarck, North Dakota, Spojené státy, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Spojené státy, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Spojené státy, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Spojené státy, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, Spojené státy, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Spojené státy, 58102
- MeritCare Broadway
-
Fargo, North Dakota, Spojené státy, 58122
- Roger Maris Cancer Center at MeritCare Hospital
-
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Ohio
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Bowling Green, Ohio, Spojené státy, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, Spojené státy, 45601
- Adena Regional Medical Center
-
Columbus, Ohio, Spojené státy, 43214-3998
- Riverside Methodist Hospital Cancer Care
-
Columbus, Ohio, Spojené státy, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, Spojené státy, 43215
- CCOP - Columbus
-
Columbus, Ohio, Spojené státy, 43215
- Grant Medical Center Cancer Care
-
Columbus, Ohio, Spojené státy, 43228
- Doctors Hospital at Ohio Health
-
Delaware, Ohio, Spojené státy, 43015
- Grady Memorial Hospital
-
Elyria, Ohio, Spojené státy, 44035
- Community Cancer Center
-
Elyria, Ohio, Spojené státy, 44035
- Hematology Oncology Center
-
Lancaster, Ohio, Spojené státy, 43130
- Fairfield Medical Center
-
Lima, Ohio, Spojené státy, 45804
- Lima Memorial Hospital
-
Marietta, Ohio, Spojené státy, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee, Ohio, Spojené státy, 43537-1839
- Northwest Ohio Oncology Center
-
Mount Vernon, Ohio, Spojené státy, 43050
- Knox Community Hospital
-
Newark, Ohio, Spojené státy, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
-
Norwalk, Ohio, Spojené státy, 44857
- Fisher-Titus Medical Center
-
Oregon, Ohio, Spojené státy, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Spojené státy, 43616
- Toledo Clinic - Oregon
-
Portsmouth, Ohio, Spojené státy, 45662
- Southern Ohio Medical Center Cancer Center
-
Sandusky, Ohio, Spojené státy, 44870
- North Coast Cancer Care, Incorporated
-
Springfield, Ohio, Spojené státy, 45505
- Community Hospital of Springfield and Clark County
-
Sylvania, Ohio, Spojené státy, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, Spojené státy, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Spojené státy, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Spojené státy, 43606
- Toledo Hospital
-
Toledo, Ohio, Spojené státy, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Spojené státy, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Spojené státy, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Toledo, Ohio, Spojené státy, 43623
- St. Anne Mercy Hospital
-
Wauseon, Ohio, Spojené státy, 43567
- Fulton County Health Center
-
Westerville, Ohio, Spojené státy, 43081
- Mount Carmel St. Ann's Cancer Center
-
Zanesville, Ohio, Spojené státy, 43701
- Genesis - Good Samaritan Hospital
-
-
Oklahoma
-
Tulsa, Oklahoma, Spojené státy, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Oregon
-
Clackamas, Oregon, Spojené státy, 97015
- Clackamas Radiation Oncology Center
-
Milwaukie, Oregon, Spojené státy, 97222
- Providence Milwaukie Hospital
-
Newberg, Oregon, Spojené státy, 97132
- Providence Newberg Medical Center
-
Oregon City, Oregon, Spojené státy, 97045
- Willamette Falls Hospital
-
Portland, Oregon, Spojené státy, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
-
Portland, Oregon, Spojené státy, 97225
- CCOP - Columbia River Oncology Program
-
Portland, Oregon, Spojené státy, 97225
- Providence St. Vincent Medical Center
-
-
Pennsylvania
-
Danville, Pennsylvania, Spojené státy, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
-
Hazleton, Pennsylvania, Spojené státy, 18201
- Geisinger Hazleton Cancer Center
-
State College, Pennsylvania, Spojené státy, 16801
- Geisinger Medical Group - Scenery Park
-
Wilkes-Barre, Pennsylvania, Spojené státy, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Spojené státy, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Spojené státy, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, Spojené státy, 22401
- Fredericksburg Oncology, Incorporated
-
Richmond, Virginia, Spojené státy, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
-
-
Washington
-
Seattle, Washington, Spojené státy, 98101
- Virginia Mason Medical Center
-
Seattle, Washington, Spojené státy, 98101
- CCOP - Virginia Mason Research Center
-
Vancouver, Washington, Spojené státy, 98664
- Southwest Washington Medical Center Cancer Center
-
-
Wisconsin
-
Chippewa Falls, Wisconsin, Spojené státy, 54729
- Marshfield Clinic - Chippewa Center
-
Eau Claire, Wisconsin, Spojené státy, 54701
- Marshfield Clinic Cancer Care at Regional Cancer Center
-
Fond du Lac, Wisconsin, Spojené státy, 54935
- Central Wisconsin Cancer Program at Agnesian HealthCare
-
Green Bay, Wisconsin, Spojené státy, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Spojené státy, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Spojené státy, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Spojené státy, 54303
- St. Mary's Hospital Medical Center - Green Bay
-
Manitowoc, Wisconsin, Spojené státy, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
-
Marinette, Wisconsin, Spojené státy, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
-
Marshfield, Wisconsin, Spojené státy, 54449
- Marshfield Clinic - Marshfield Center
-
Minocqua, Wisconsin, Spojené státy, 54548
- Marshfield Clinic - Lakeland Center
-
Oconto Falls, Wisconsin, Spojené státy, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Rhinelander, Wisconsin, Spojené státy, 54501
- Ministry Medical Group at Saint Mary's Hospital
-
Rice Lake, Wisconsin, Spojené státy, 54868
- Marshfield Clinic - Indianhead Center
-
Sheboygan, Wisconsin, Spojené státy, 53081
- St. Nicholas Hospital
-
Stevens Point, Wisconsin, Spojené státy, 54481
- Marshfield Clinic at Saint Michael's Hospital
-
Sturgeon Bay, Wisconsin, Spojené státy, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
Weston, Wisconsin, Spojené státy, 54476
- Marshfield Clinic - Weston Center
-
Wisconsin Rapids, Wisconsin, Spojené státy, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Wyoming
-
Sheridan, Wyoming, Spojené státy, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
Planning to receive paclitaxel IV (excluding paclitaxel albumin-stabilized nanoparticle formulation [nab-paclitaxel]) according to one of the following dosing schedules:
- At least 175 mg/m^2 at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively)
- 70-90 mg/m^2 weekly (3 out of 4 weeks allowed)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 6 months
- Able to complete questionnaires (alone or with assistance)
- Willing to provide required biological specimens
- No prior or concurrent peripheral neuropathy (from diabetes or other causes)
- No prior or concurrent fibromyalgia
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior paclitaxel or neurotoxic chemotherapy drugs, including other taxanes, platinum agents, vinca alkaloids, or epothilones
- No concurrent neutrophil colony-stimulating factor therapy
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
Group I
Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year.
Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.
|
|
Group II
Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year.
Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.
|
|
Group III
Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year.
Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.
|
|
Group IV
Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year.
Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy)
Časové okno: Up to day 7
|
Up to day 7
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Maximum of the average pain score
Časové okno: Up to 12 months
|
Up to 12 months
|
Area under the curve of worst, average, and least pain
Časové okno: Up to 12 months
|
Up to 12 months
|
Worst pain reported for the overall week
Časové okno: Up to 12 months
|
Up to 12 months
|
Rate of non-prescription pain medication use
Časové okno: Up to 12 months
|
Up to 12 months
|
Rate of opioid use
Časové okno: Up to 12 months
|
Up to 12 months
|
Rate of other pain therapy use
Časové okno: Up to 12 months
|
Up to 12 months
|
Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores
Časové okno: Up to 12 months
|
Up to 12 months
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- Reeves BN, Dakhil SR, Sloan JA, Wolf SL, Burger KN, Kamal A, Le-Lindqwister NA, Soori GS, Jaslowski AJ, Kelaghan J, Novotny PJ, Lachance DH, Loprinzi CL. Further data supporting that paclitaxel-associated acute pain syndrome is associated with development of peripheral neuropathy: North Central Cancer Treatment Group trial N08C1. Cancer. 2012 Oct 15;118(20):5171-8. doi: 10.1002/cncr.27489. Epub 2012 Mar 13.
- Loprinzi CL, Reeves BN, Dakhil SR, Sloan JA, Wolf SL, Burger KN, Kamal A, Le-Lindqwister NA, Soori GS, Jaslowski AJ, Novotny PJ, Lachance DH. Natural history of paclitaxel-associated acute pain syndrome: prospective cohort study NCCTG N08C1. J Clin Oncol. 2011 Apr 10;29(11):1472-8. doi: 10.1200/JCO.2010.33.0308. Epub 2011 Mar 7.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NCCTG-N08C1
- NCI-2009-01108 (Identifikátor registru: CTRP (Clinical Trials Reporting System))
- CDR0000631962 (Identifikátor registru: PDQ (Physician Data Query))
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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