- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Colorado
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Aurora, Colorado, Stati Uniti, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Stati Uniti, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Stati Uniti, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Stati Uniti, 80210
- Porter Adventist Hospital
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Denver, Colorado, Stati Uniti, 80220
- Rose Medical Center
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Denver, Colorado, Stati Uniti, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Stati Uniti, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Stati Uniti, 80218
- St. Joseph Hospital
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Denver, Colorado, Stati Uniti, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Stati Uniti, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Stati Uniti, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Stati Uniti, 80631
- North Colorado Medical Center
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Littleton, Colorado, Stati Uniti, 80122
- Littleton Adventist Hospital
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Lone Tree, Colorado, Stati Uniti, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Stati Uniti, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Stati Uniti, 80539
- McKee Medical Center
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Parker, Colorado, Stati Uniti, 80138
- Parker Adventist Hospital
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Pueblo, Colorado, Stati Uniti, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Stati Uniti, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Stati Uniti, 80033
- Exempla Lutheran Medical Center
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Connecticut
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Hartford, Connecticut, Stati Uniti, 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, Stati Uniti, 96701
- Kapiolani Medical Center at Pali Momi
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Honolulu, Hawaii, Stati Uniti, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Stati Uniti, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Stati Uniti, 96813
- OnCare Hawaii, Incorporated - Lusitana
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Honolulu, Hawaii, Stati Uniti, 96813
- Queen's Cancer Institute at Queen's Medical Center
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Honolulu, Hawaii, Stati Uniti, 96813
- Straub Clinic and Hospital, Incorporated
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Honolulu, Hawaii, Stati Uniti, 96817
- Hawaii Medical Center - East
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Honolulu, Hawaii, Stati Uniti, 96817
- OnCare Hawaii, Incorporated - Kuakini
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Honolulu, Hawaii, Stati Uniti, 96859
- Tripler Army Medical Center
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Lihue, Hawaii, Stati Uniti, 96766
- Kauai Medical Clinic
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Wailuku, Hawaii, Stati Uniti, 96793
- Maui Memorial Medical Center
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Wailuku, Hawaii, Stati Uniti, 96793
- Pacific Cancer Institute - Maui
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Idaho
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Boise, Idaho, Stati Uniti, 83706
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
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Illinois
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Bloomington, Illinois, Stati Uniti, 61701
- St. Joseph Medical Center
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Bloomington%, Illinois, Stati Uniti, 61701
- Illinois CancerCare - Bloomington
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Canton, Illinois, Stati Uniti, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Stati Uniti, 61520
- Graham Hospital
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Carthage, Illinois, Stati Uniti, 62321
- Memorial Hospital
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Carthage, Illinois, Stati Uniti, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Stati Uniti, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Stati Uniti, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Stati Uniti, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, Stati Uniti, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Stati Uniti, 62644
- Mason District Hospital
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Havana, Illinois, Stati Uniti, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Stati Uniti, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Stati Uniti, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Stati Uniti, 61455
- Mcdonough District Hospital
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Moline, Illinois, Stati Uniti, 61265
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Moline, Illinois, Stati Uniti, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Stati Uniti, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, Stati Uniti, 61462
- OSF Holy Family Medical Center
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Normal, Illinois, Stati Uniti, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Stati Uniti, 61761
- Community Cancer Center
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Normal, Illinois, Stati Uniti, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Stati Uniti, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Stati Uniti, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Stati Uniti, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Stati Uniti, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Stati Uniti, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Stati Uniti, 61614
- Proctor Hospital
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Peoria, Illinois, Stati Uniti, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Stati Uniti, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Stati Uniti, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Stati Uniti, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Stati Uniti, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Stati Uniti, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Stati Uniti, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Stati Uniti, 61362
- Illinois CancerCare - Spring Valley
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Indiana
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Elkhart, Indiana, Stati Uniti, 46515
- Elkhart General Hospital
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Elkhart, Indiana, Stati Uniti, 46514
- Michiana Hematology-Oncology, PC - Elkhart
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Kokomo, Indiana, Stati Uniti, 46904
- Howard Community Hospital
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La Porte, Indiana, Stati Uniti, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, Stati Uniti, 46545-1470
- Michiana Hematology-Oncology, PC - South Bend
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Mishawaka, Indiana, Stati Uniti, 46545-1470
- Saint Joseph Regional Medical Center
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Plymouth, Indiana, Stati Uniti, 46563
- Michiana Hematology Oncology PC - Plymouth
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South Bend, Indiana, Stati Uniti, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Stati Uniti, 46601
- CCOP - Northern Indiana CR Consortium
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Westville, Indiana, Stati Uniti, 46391
- Michiana Hematology Oncology PC - La Porte
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Iowa
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Ames, Iowa, Stati Uniti, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, Stati Uniti, 52722
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Clive, Iowa, Stati Uniti, 50325
- Medical Oncology and Hematology Associates - West Des Moines
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Des Moines, Iowa, Stati Uniti, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Stati Uniti, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Stati Uniti, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Stati Uniti, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Stati Uniti, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stati Uniti, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Mason City, Iowa, Stati Uniti, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, Stati Uniti, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, Stati Uniti, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Stati Uniti, 51102
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, Stati Uniti, 51104
- St. Luke's Regional Medical Center
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Kansas
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Chanute, Kansas, Stati Uniti, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Stati Uniti, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Stati Uniti, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Stati Uniti, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Stati Uniti, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Stati Uniti, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Stati Uniti, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Stati Uniti, 67901
- Cancer Center of Kansas, PA - Liberal
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McPherson, Kansas, Stati Uniti, 67460
- Cancer Center of Kansas, PA - McPherson
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Newton, Kansas, Stati Uniti, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Stati Uniti, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Stati Uniti, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Stati Uniti, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Stati Uniti, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Stati Uniti, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Stati Uniti, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Stati Uniti, 67214
- CCOP - Wichita
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Wichita, Kansas, Stati Uniti, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Stati Uniti, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Stati Uniti, 67156
- Cancer Center of Kansas, PA - Winfield
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70809
- Ochsner Health Center - Bluebonnet
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New Orleans, Louisiana, Stati Uniti, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Stati Uniti, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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Michigan
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Adrian, Michigan, Stati Uniti, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Stati Uniti, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Stati Uniti, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Stati Uniti, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Stati Uniti, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, Stati Uniti, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Stati Uniti, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Stati Uniti, 48503
- Hurley Medical Center
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Flint, Michigan, Stati Uniti, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Stati Uniti, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Stati Uniti, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Stati Uniti, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, Stati Uniti, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Stati Uniti, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Stati Uniti, 49201
- Foote Memorial Hospital
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Lansing, Michigan, Stati Uniti, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Stati Uniti, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, Stati Uniti, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Stati Uniti, 48162
- Mercy Memorial Hospital - Monroe
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Muskegon, Michigan, Stati Uniti, 49443
- Mercy General Health Partners
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Pontiac, Michigan, Stati Uniti, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Stati Uniti, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Stati Uniti, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Saint Joseph, Michigan, Stati Uniti, 49085
- Lakeside Cancer Specialists, PLLC
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St. Joseph, Michigan, Stati Uniti, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Traverse City, Michigan, Stati Uniti, 49684
- Munson Medical Center
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Warren, Michigan, Stati Uniti, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, Stati Uniti, 56308
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Bemidji, Minnesota, Stati Uniti, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Stati Uniti, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Stati Uniti, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Stati Uniti, 55805
- CCOP - Duluth
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Duluth, Minnesota, Stati Uniti, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Stati Uniti, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Stati Uniti, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Stati Uniti, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Stati Uniti, 55350
- Hutchinson Area Health Care
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Mankato, Minnesota, Stati Uniti, 56002
- Immanuel St. Joseph's
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Maplewood, Minnesota, Stati Uniti, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, Stati Uniti, 55109
- Minnesota Oncology - Maplewood
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Minneapolis, Minnesota, Stati Uniti, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Stati Uniti, 55415
- Hennepin County Medical Center - Minneapolis
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New Ulm, Minnesota, Stati Uniti, 56073
- New Ulm Medical Center
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Robbinsdale, Minnesota, Stati Uniti, 55422-2900
- Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Stati Uniti, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Stati Uniti, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Stati Uniti, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Stati Uniti, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Stati Uniti, 55102
- United Hospital
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Shakopee, Minnesota, Stati Uniti, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St. Paul, Minnesota, Stati Uniti, 55101
- Regions Hospital Cancer Care Center
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Stillwater, Minnesota, Stati Uniti, 55082
- Lakeview Hospital
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Waconia, Minnesota, Stati Uniti, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Stati Uniti, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, Stati Uniti, 55125
- Minnesota Oncology - Woodbury
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Missouri
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Cape Girardeau, Missouri, Stati Uniti, 63703
- Southeast Cancer Center
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Jefferson City, Missouri, Stati Uniti, 65109
- Goldschmidt Cancer Center
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Saint Louis, Missouri, Stati Uniti, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, Stati Uniti, 63141
- Comprehensive Cancer Care, PC
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Montana
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Billings, Montana, Stati Uniti, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Stati Uniti, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Stati Uniti, 59107-7000
- Billings Clinic - Downtown
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Billings, Montana, Stati Uniti, 59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Bozeman, Montana, Stati Uniti, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Stati Uniti, 59701
- St. James Healthcare Cancer Care
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Great Falls, Montana, Stati Uniti, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Stati Uniti, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Havre, Montana, Stati Uniti, 59501
- Northern Montana Hospital
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Helena, Montana, Stati Uniti, 59601
- St. Peter's Hospital
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Kalispell, Montana, Stati Uniti, 59901
- Kalispell Regional Medical Center
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Kalispell, Montana, Stati Uniti, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Stati Uniti, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Stati Uniti, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Stati Uniti, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Lincoln, Nebraska, Stati Uniti, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Stati Uniti, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Stati Uniti, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Stati Uniti, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Stati Uniti, 68131-2197
- Creighton University Medical Center
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Omaha, Nebraska, Stati Uniti, 68130
- Lakeside Hospital
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North Dakota
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Bismarck, North Dakota, Stati Uniti, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Stati Uniti, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Stati Uniti, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Stati Uniti, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Stati Uniti, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Stati Uniti, 58102
- MeritCare Broadway
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Fargo, North Dakota, Stati Uniti, 58122
- Roger Maris Cancer Center at MeritCare Hospital
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Ohio
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Bowling Green, Ohio, Stati Uniti, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, Stati Uniti, 45601
- Adena Regional Medical Center
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Columbus, Ohio, Stati Uniti, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Stati Uniti, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, Stati Uniti, 43215
- CCOP - Columbus
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Columbus, Ohio, Stati Uniti, 43215
- Grant Medical Center Cancer Care
-
Columbus, Ohio, Stati Uniti, 43228
- Doctors Hospital at Ohio Health
-
Delaware, Ohio, Stati Uniti, 43015
- Grady Memorial Hospital
-
Elyria, Ohio, Stati Uniti, 44035
- Community Cancer Center
-
Elyria, Ohio, Stati Uniti, 44035
- Hematology Oncology Center
-
Lancaster, Ohio, Stati Uniti, 43130
- Fairfield Medical Center
-
Lima, Ohio, Stati Uniti, 45804
- Lima Memorial Hospital
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Marietta, Ohio, Stati Uniti, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Maumee, Ohio, Stati Uniti, 43537-1839
- Northwest Ohio Oncology Center
-
Mount Vernon, Ohio, Stati Uniti, 43050
- Knox Community Hospital
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Newark, Ohio, Stati Uniti, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Norwalk, Ohio, Stati Uniti, 44857
- Fisher-Titus Medical Center
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Oregon, Ohio, Stati Uniti, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Stati Uniti, 43616
- Toledo Clinic - Oregon
-
Portsmouth, Ohio, Stati Uniti, 45662
- Southern Ohio Medical Center Cancer Center
-
Sandusky, Ohio, Stati Uniti, 44870
- North Coast Cancer Care, Incorporated
-
Springfield, Ohio, Stati Uniti, 45505
- Community Hospital of Springfield and Clark County
-
Sylvania, Ohio, Stati Uniti, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, Stati Uniti, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Stati Uniti, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Stati Uniti, 43606
- Toledo Hospital
-
Toledo, Ohio, Stati Uniti, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Stati Uniti, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Stati Uniti, 43623
- Toledo Clinic, Incorporated - Main Clinic
-
Toledo, Ohio, Stati Uniti, 43623
- St. Anne Mercy Hospital
-
Wauseon, Ohio, Stati Uniti, 43567
- Fulton County Health Center
-
Westerville, Ohio, Stati Uniti, 43081
- Mount Carmel St. Ann's Cancer Center
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Zanesville, Ohio, Stati Uniti, 43701
- Genesis - Good Samaritan Hospital
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Oklahoma
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Tulsa, Oklahoma, Stati Uniti, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Oregon
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Clackamas, Oregon, Stati Uniti, 97015
- Clackamas Radiation Oncology Center
-
Milwaukie, Oregon, Stati Uniti, 97222
- Providence Milwaukie Hospital
-
Newberg, Oregon, Stati Uniti, 97132
- Providence Newberg Medical Center
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Oregon City, Oregon, Stati Uniti, 97045
- Willamette Falls Hospital
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Portland, Oregon, Stati Uniti, 97213-2967
- Providence Cancer Center at Providence Portland Medical Center
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Portland, Oregon, Stati Uniti, 97225
- CCOP - Columbia River Oncology Program
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Portland, Oregon, Stati Uniti, 97225
- Providence St. Vincent Medical Center
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Pennsylvania
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Danville, Pennsylvania, Stati Uniti, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hazleton, Pennsylvania, Stati Uniti, 18201
- Geisinger Hazleton Cancer Center
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State College, Pennsylvania, Stati Uniti, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, Stati Uniti, 18711
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
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South Dakota
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Rapid City, South Dakota, Stati Uniti, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Stati Uniti, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Virginia
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Fredericksburg, Virginia, Stati Uniti, 22401
- Fredericksburg Oncology, Incorporated
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Richmond, Virginia, Stati Uniti, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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Washington
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Seattle, Washington, Stati Uniti, 98101
- Virginia Mason Medical Center
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Seattle, Washington, Stati Uniti, 98101
- CCOP - Virginia Mason Research Center
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Vancouver, Washington, Stati Uniti, 98664
- Southwest Washington Medical Center Cancer Center
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Wisconsin
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Chippewa Falls, Wisconsin, Stati Uniti, 54729
- Marshfield Clinic - Chippewa Center
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Eau Claire, Wisconsin, Stati Uniti, 54701
- Marshfield Clinic Cancer Care at Regional Cancer Center
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Fond du Lac, Wisconsin, Stati Uniti, 54935
- Central Wisconsin Cancer Program at Agnesian HealthCare
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Green Bay, Wisconsin, Stati Uniti, 54307-3508
- St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Stati Uniti, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
-
Green Bay, Wisconsin, Stati Uniti, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Stati Uniti, 54303
- St. Mary's Hospital Medical Center - Green Bay
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Manitowoc, Wisconsin, Stati Uniti, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
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Marinette, Wisconsin, Stati Uniti, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Marshfield, Wisconsin, Stati Uniti, 54449
- Marshfield Clinic - Marshfield Center
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Minocqua, Wisconsin, Stati Uniti, 54548
- Marshfield Clinic - Lakeland Center
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Oconto Falls, Wisconsin, Stati Uniti, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Rhinelander, Wisconsin, Stati Uniti, 54501
- Ministry Medical Group at Saint Mary's Hospital
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Rice Lake, Wisconsin, Stati Uniti, 54868
- Marshfield Clinic - Indianhead Center
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Sheboygan, Wisconsin, Stati Uniti, 53081
- St. Nicholas Hospital
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Stevens Point, Wisconsin, Stati Uniti, 54481
- Marshfield Clinic at Saint Michael's Hospital
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Sturgeon Bay, Wisconsin, Stati Uniti, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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Weston, Wisconsin, Stati Uniti, 54476
- Marshfield Clinic - Weston Center
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Wisconsin Rapids, Wisconsin, Stati Uniti, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Wyoming
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Sheridan, Wyoming, Stati Uniti, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
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|
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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.
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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.
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|
|
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy)
Lasso di tempo: Up to day 7
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Up to day 7
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Maximum of the average pain score
Lasso di tempo: Up to 12 months
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Up to 12 months
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Area under the curve of worst, average, and least pain
Lasso di tempo: Up to 12 months
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Up to 12 months
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Worst pain reported for the overall week
Lasso di tempo: Up to 12 months
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Up to 12 months
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Rate of non-prescription pain medication use
Lasso di tempo: Up to 12 months
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Up to 12 months
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Rate of opioid use
Lasso di tempo: Up to 12 months
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Up to 12 months
|
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Rate of other pain therapy use
Lasso di tempo: Up to 12 months
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Up to 12 months
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Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores
Lasso di tempo: Up to 12 months
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Up to 12 months
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Collaboratori e investigatori
Collaboratori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NCCTG-N08C1
- NCI-2009-01108 (Identificatore di registro: CTRP (Clinical Trials Reporting System))
- CDR0000631962 (Identificatore di registro: PDQ (Physician Data Query))
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .