Acute Pain Caused by Paclitaxel in Patients With Cancer
12. juli 2016 opdateret af: Alliance for Clinical Trials in Oncology
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
306
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Forenede Stater, 80301-9019
- Boulder Community Hospital
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Colorado Springs, Colorado, Forenede Stater, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Forenede Stater, 80210
- Porter Adventist Hospital
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Denver, Colorado, Forenede Stater, 80220
- Rose Medical Center
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Denver, Colorado, Forenede Stater, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Forenede Stater, 80204
- St. Anthony Central Hospital
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Denver, Colorado, Forenede Stater, 80218
- St. Joseph Hospital
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Denver, Colorado, Forenede Stater, 80224-2522
- CCOP - Colorado Cancer Research Program
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Englewood, Colorado, Forenede Stater, 80110
- Swedish Medical Center
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Grand Junction, Colorado, Forenede Stater, 81502
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
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Greeley, Colorado, Forenede Stater, 80631
- North Colorado Medical Center
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Littleton, Colorado, Forenede Stater, 80122
- Littleton Adventist Hospital
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Lone Tree, Colorado, Forenede Stater, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Forenede Stater, 80501
- Hope Cancer Care Center at Longmont United Hospital
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Loveland, Colorado, Forenede Stater, 80539
- McKee Medical Center
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Parker, Colorado, Forenede Stater, 80138
- Parker Adventist Hospital
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Pueblo, Colorado, Forenede Stater, 81004
- St. Mary - Corwin Regional Medical Center
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Thornton, Colorado, Forenede Stater, 80229
- North Suburban Medical Center
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Wheat Ridge, Colorado, Forenede Stater, 80033
- Exempla Lutheran Medical Center
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Connecticut
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Hartford, Connecticut, Forenede Stater, 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, Forenede Stater, 96701
- Kapiolani Medical Center at Pali Momi
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Honolulu, Hawaii, Forenede Stater, 96813
- Cancer Research Center of Hawaii
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Honolulu, Hawaii, Forenede Stater, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Forenede Stater, 96813
- OnCare Hawaii, Incorporated - Lusitana
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Honolulu, Hawaii, Forenede Stater, 96813
- Queen's Cancer Institute at Queen's Medical Center
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Honolulu, Hawaii, Forenede Stater, 96813
- Straub Clinic and Hospital, Incorporated
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Honolulu, Hawaii, Forenede Stater, 96817
- Hawaii Medical Center - East
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Honolulu, Hawaii, Forenede Stater, 96817
- OnCare Hawaii, Incorporated - Kuakini
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Honolulu, Hawaii, Forenede Stater, 96859
- Tripler Army Medical Center
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Lihue, Hawaii, Forenede Stater, 96766
- Kauai Medical Clinic
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Wailuku, Hawaii, Forenede Stater, 96793
- Maui Memorial Medical Center
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Wailuku, Hawaii, Forenede Stater, 96793
- Pacific Cancer Institute - Maui
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Idaho
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Boise, Idaho, Forenede Stater, 83706
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
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Illinois
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Bloomington, Illinois, Forenede Stater, 61701
- St. Joseph Medical Center
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Bloomington%, Illinois, Forenede Stater, 61701
- Illinois CancerCare - Bloomington
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Canton, Illinois, Forenede Stater, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Forenede Stater, 61520
- Graham Hospital
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Carthage, Illinois, Forenede Stater, 62321
- Memorial Hospital
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Carthage, Illinois, Forenede Stater, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Forenede Stater, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Forenede Stater, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Forenede Stater, 62644
- Mason District Hospital
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Havana, Illinois, Forenede Stater, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Forenede Stater, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Forenede Stater, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Forenede Stater, 61455
- Mcdonough District Hospital
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Moline, Illinois, Forenede Stater, 61265
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Moline, Illinois, Forenede Stater, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Forenede Stater, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, Forenede Stater, 61462
- OSF Holy Family Medical Center
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Normal, Illinois, Forenede Stater, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Forenede Stater, 61761
- Community Cancer Center
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Normal, Illinois, Forenede Stater, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Forenede Stater, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Forenede Stater, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Forenede Stater, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Forenede Stater, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Forenede Stater, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Forenede Stater, 61614
- Proctor Hospital
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Peoria, Illinois, Forenede Stater, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Forenede Stater, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Forenede Stater, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Forenede Stater, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Forenede Stater, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Forenede Stater, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Forenede Stater, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Forenede Stater, 61362
- Illinois CancerCare - Spring Valley
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Indiana
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Elkhart, Indiana, Forenede Stater, 46515
- Elkhart General Hospital
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Elkhart, Indiana, Forenede Stater, 46514
- Michiana Hematology-Oncology, PC - Elkhart
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Kokomo, Indiana, Forenede Stater, 46904
- Howard Community Hospital
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La Porte, Indiana, Forenede Stater, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, Forenede Stater, 46545-1470
- Michiana Hematology-Oncology, PC - South Bend
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Mishawaka, Indiana, Forenede Stater, 46545-1470
- Saint Joseph Regional Medical Center
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Plymouth, Indiana, Forenede Stater, 46563
- Michiana Hematology Oncology PC - Plymouth
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South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Forenede Stater, 46601
- CCOP - Northern Indiana CR Consortium
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Westville, Indiana, Forenede Stater, 46391
- Michiana Hematology Oncology PC - La Porte
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Iowa
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Ames, Iowa, Forenede Stater, 50010
- McFarland Clinic, PC
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Bettendorf, Iowa, Forenede Stater, 52722
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Cedar Rapids, Iowa, Forenede Stater, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Forenede Stater, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Clive, Iowa, Forenede Stater, 50325
- Medical Oncology and Hematology Associates - West Des Moines
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Des Moines, Iowa, Forenede Stater, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Forenede Stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Forenede Stater, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Forenede Stater, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Forenede Stater, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Forenede Stater, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Mason City, Iowa, Forenede Stater, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, Forenede Stater, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, Forenede Stater, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Forenede Stater, 51102
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, Forenede Stater, 51104
- St. Luke's Regional Medical Center
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Kansas
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Chanute, Kansas, Forenede Stater, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Forenede Stater, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Forenede Stater, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Forenede Stater, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Forenede Stater, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Forenede Stater, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Forenede Stater, 67901
- Cancer Center of Kansas, PA - Liberal
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McPherson, Kansas, Forenede Stater, 67460
- Cancer Center of Kansas, PA - McPherson
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Newton, Kansas, Forenede Stater, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Forenede Stater, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Forenede Stater, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Forenede Stater, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Forenede Stater, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Forenede Stater, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Forenede Stater, 67214
- CCOP - Wichita
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Wichita, Kansas, Forenede Stater, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Forenede Stater, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Forenede Stater, 67156
- Cancer Center of Kansas, PA - Winfield
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Ochsner Health Center - Bluebonnet
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New Orleans, Louisiana, Forenede Stater, 70121
- CCOP - Ochsner
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New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Cancer Institute at Ochsner Clinic Foundation
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Michigan
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Adrian, Michigan, Forenede Stater, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Forenede Stater, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Forenede Stater, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Forenede Stater, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Forenede Stater, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, Forenede Stater, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Escanaba, Michigan, Forenede Stater, 49431
- Green Bay Oncology, Limited - Escanaba
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Forenede Stater, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Forenede Stater, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Forenede Stater, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, Forenede Stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Iron Mountain, Michigan, Forenede Stater, 49801
- Dickinson County Healthcare System
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Jackson, Michigan, Forenede Stater, 49201
- Foote Memorial Hospital
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Lansing, Michigan, Forenede Stater, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Forenede Stater, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, Forenede Stater, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Forenede Stater, 48162
- Mercy Memorial Hospital - Monroe
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Muskegon, Michigan, Forenede Stater, 49443
- Mercy General Health Partners
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Pontiac, Michigan, Forenede Stater, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Forenede Stater, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Forenede Stater, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Saint Joseph, Michigan, Forenede Stater, 49085
- Lakeside Cancer Specialists, PLLC
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St. Joseph, Michigan, Forenede Stater, 49085
- Lakeland Regional Cancer Care Center - St. Joseph
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Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
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Warren, Michigan, Forenede Stater, 48093
- St. John Macomb Hospital
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Minnesota
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Alexandria, Minnesota, Forenede Stater, 56308
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Bemidji, Minnesota, Forenede Stater, 56601
- MeritCare Bemidji
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Duluth, Minnesota, Forenede Stater, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Forenede Stater, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Forenede Stater, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Forenede Stater, 55350
- Hutchinson Area Health Care
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Mankato, Minnesota, Forenede Stater, 56002
- Immanuel St. Joseph's
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Maplewood, Minnesota, Forenede Stater, 55109
- HealthEast Cancer Care at St. John's Hospital
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Maplewood, Minnesota, Forenede Stater, 55109
- Minnesota Oncology - Maplewood
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Minneapolis, Minnesota, Forenede Stater, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Forenede Stater, 55415
- Hennepin County Medical Center - Minneapolis
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New Ulm, Minnesota, Forenede Stater, 56073
- New Ulm Medical Center
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Robbinsdale, Minnesota, Forenede Stater, 55422-2900
- Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Forenede Stater, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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Shakopee, Minnesota, Forenede Stater, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St. Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital Cancer Care Center
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Stillwater, Minnesota, Forenede Stater, 55082
- Lakeview Hospital
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Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Forenede Stater, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology - Woodbury
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63703
- Southeast Cancer Center
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Jefferson City, Missouri, Forenede Stater, 65109
- Goldschmidt Cancer Center
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Saint Louis, Missouri, Forenede Stater, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, Forenede Stater, 63141
- Comprehensive Cancer Care, PC
-
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Montana
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Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Forenede Stater, 59101
- St. Vincent Healthcare Cancer Care Services
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Billings, Montana, Forenede Stater, 59107-7000
- Billings Clinic - Downtown
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Billings, Montana, Forenede Stater, 59102
- Hematology-Oncology Centers of the Northern Rockies - Billings
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Bozeman, Montana, Forenede Stater, 59715
- Bozeman Deaconess Cancer Center
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Butte, Montana, Forenede Stater, 59701
- St. James Healthcare Cancer Care
-
Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic - Main Facility
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Great Falls, Montana, Forenede Stater, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Havre, Montana, Forenede Stater, 59501
- Northern Montana Hospital
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Helena, Montana, Forenede Stater, 59601
- St. Peter's Hospital
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Kalispell, Montana, Forenede Stater, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, Forenede Stater, 59901
- Glacier Oncology, PLLC
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Kalispell, Montana, Forenede Stater, 59901
- Kalispell Medical Oncology at KRMC
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Missoula, Montana, Forenede Stater, 59807-7877
- Montana Cancer Specialists at Montana Cancer Center
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Missoula, Montana, Forenede Stater, 59807
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Forenede Stater, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Forenede Stater, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Forenede Stater, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Forenede Stater, 68131-2197
- Creighton University Medical Center
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Omaha, Nebraska, Forenede Stater, 68130
- Lakeside Hospital
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North Dakota
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Bismarck, North Dakota, Forenede Stater, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Forenede Stater, 58501
- Medcenter One Hospital Cancer Care Center
-
Bismarck, North Dakota, Forenede Stater, 58501
- Mid Dakota Clinic, PC
-
Bismarck, North Dakota, Forenede Stater, 58502
- St. Alexius Medical Center Cancer Center
-
Fargo, North Dakota, Forenede Stater, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Forenede Stater, 58102
- MeritCare Broadway
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Fargo, North Dakota, Forenede Stater, 58122
- Roger Maris Cancer Center at MeritCare Hospital
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Ohio
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Bowling Green, Ohio, Forenede Stater, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, Forenede Stater, 45601
- Adena Regional Medical Center
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Columbus, Ohio, Forenede Stater, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Forenede Stater, 43222
- Mount Carmel Health - West Hospital
-
Columbus, Ohio, Forenede Stater, 43215
- CCOP - Columbus
-
Columbus, Ohio, Forenede Stater, 43215
- Grant Medical Center Cancer Care
-
Columbus, Ohio, Forenede Stater, 43228
- Doctors Hospital at Ohio Health
-
Delaware, Ohio, Forenede Stater, 43015
- Grady Memorial Hospital
-
Elyria, Ohio, Forenede Stater, 44035
- Community Cancer Center
-
Elyria, Ohio, Forenede Stater, 44035
- Hematology Oncology Center
-
Lancaster, Ohio, Forenede Stater, 43130
- Fairfield Medical Center
-
Lima, Ohio, Forenede Stater, 45804
- Lima Memorial Hospital
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Marietta, Ohio, Forenede Stater, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
-
Maumee, Ohio, Forenede Stater, 43537-1839
- Northwest Ohio Oncology Center
-
Mount Vernon, Ohio, Forenede Stater, 43050
- Knox Community Hospital
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Newark, Ohio, Forenede Stater, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Norwalk, Ohio, Forenede Stater, 44857
- Fisher-Titus Medical Center
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Oregon, Ohio, Forenede Stater, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Forenede Stater, 43616
- Toledo Clinic - Oregon
-
Portsmouth, Ohio, Forenede Stater, 45662
- Southern Ohio Medical Center Cancer Center
-
Sandusky, Ohio, Forenede Stater, 44870
- North Coast Cancer Care, Incorporated
-
Springfield, Ohio, Forenede Stater, 45505
- Community Hospital of Springfield and Clark County
-
Sylvania, Ohio, Forenede Stater, 43560
- Flower Hospital Cancer Center
-
Tiffin, Ohio, Forenede Stater, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Forenede Stater, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Forenede Stater, 43606
- Toledo Hospital
-
Toledo, Ohio, Forenede Stater, 43614
- Medical University of Ohio Cancer Center
-
Toledo, Ohio, Forenede Stater, 43617
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Forenede Stater, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, Forenede Stater, 43623
- St. Anne Mercy Hospital
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Wauseon, Ohio, Forenede Stater, 43567
- Fulton County Health Center
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Westerville, Ohio, Forenede Stater, 43081
- Mount Carmel St. Ann's Cancer Center
-
Zanesville, Ohio, Forenede Stater, 43701
- Genesis - Good Samaritan Hospital
-
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
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Oregon
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Clackamas, Oregon, Forenede Stater, 97015
- Clackamas Radiation Oncology Center
-
Milwaukie, Oregon, Forenede Stater, 97222
- Providence Milwaukie Hospital
-
Newberg, Oregon, Forenede Stater, 97132
- Providence Newberg Medical Center
-
Oregon City, Oregon, Forenede Stater, 97045
- Willamette Falls Hospital
-
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
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Pennsylvania
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Danville, Pennsylvania, Forenede Stater, 17822-0001
- Geisinger Cancer Institute at Geisinger Health
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Hazleton, Pennsylvania, Forenede Stater, 18201
- Geisinger Hazleton Cancer Center
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State College, Pennsylvania, Forenede Stater, 16801
- Geisinger Medical Group - Scenery Park
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Wilkes-Barre, Pennsylvania, Forenede Stater, 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, Forenede Stater, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Virginia
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Fredericksburg, Virginia, Forenede Stater, 22401
- Fredericksburg Oncology, Incorporated
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Richmond, Virginia, Forenede Stater, 23298-0037
- Virginia Commonwealth University Massey Cancer Center
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Washington
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Seattle, Washington, Forenede Stater, 98101
- Virginia Mason Medical Center
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Seattle, Washington, Forenede Stater, 98101
- CCOP - Virginia Mason Research Center
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Vancouver, Washington, Forenede Stater, 98664
- Southwest Washington Medical Center Cancer Center
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Wisconsin
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Chippewa Falls, Wisconsin, Forenede Stater, 54729
- Marshfield Clinic - Chippewa Center
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Eau Claire, Wisconsin, Forenede Stater, 54701
- Marshfield Clinic Cancer Care at Regional Cancer Center
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Fond du Lac, Wisconsin, Forenede Stater, 54935
- Central Wisconsin Cancer Program at Agnesian HealthCare
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Green Bay, Wisconsin, Forenede Stater, 54307-3508
- St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Forenede Stater, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
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Green Bay, Wisconsin, Forenede Stater, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Forenede Stater, 54303
- St. Mary's Hospital Medical Center - Green Bay
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Manitowoc, Wisconsin, Forenede Stater, 54221-1450
- Holy Family Memorial Medical Center Cancer Care Center
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Marinette, Wisconsin, Forenede Stater, 54143
- Bay Area Cancer Care Center at Bay Area Medical Center
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Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Clinic - Marshfield Center
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Minocqua, Wisconsin, Forenede Stater, 54548
- Marshfield Clinic - Lakeland Center
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Oconto Falls, Wisconsin, Forenede Stater, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Rhinelander, Wisconsin, Forenede Stater, 54501
- Ministry Medical Group at Saint Mary's Hospital
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Rice Lake, Wisconsin, Forenede Stater, 54868
- Marshfield Clinic - Indianhead Center
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Sheboygan, Wisconsin, Forenede Stater, 53081
- St. Nicholas Hospital
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Stevens Point, Wisconsin, Forenede Stater, 54481
- Marshfield Clinic at Saint Michael's Hospital
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Sturgeon Bay, Wisconsin, Forenede Stater, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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Weston, Wisconsin, Forenede Stater, 54476
- Marshfield Clinic - Weston Center
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Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
- Marshfield Clinic - Wisconsin Rapids Center
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Wyoming
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Sheridan, Wyoming, Forenede Stater, 82801
- Welch Cancer Center at Sheridan Memorial Hospital
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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
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients diagnosed with cancer who are planning to receive paclitaxel IV at least 175 mg/m^2 at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively) or 70-90 mg/m^2 weekly (3 out of 4 weeks allowed).
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy)
Tidsramme: Up to day 7
|
Up to day 7
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Maximum of the average pain score
Tidsramme: Up to 12 months
|
Up to 12 months
|
|
Area under the curve of worst, average, and least pain
Tidsramme: Up to 12 months
|
Up to 12 months
|
|
Worst pain reported for the overall week
Tidsramme: Up to 12 months
|
Up to 12 months
|
|
Rate of non-prescription pain medication use
Tidsramme: Up to 12 months
|
Up to 12 months
|
|
Rate of opioid use
Tidsramme: Up to 12 months
|
Up to 12 months
|
|
Rate of other pain therapy use
Tidsramme: Up to 12 months
|
Up to 12 months
|
|
Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores
Tidsramme: Up to 12 months
|
Up to 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
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. februar 2009
Primær færdiggørelse (Faktiske)
1. april 2011
Studieafslutning (Faktiske)
1. maj 2013
Datoer for studieregistrering
Først indsendt
10. marts 2009
Først indsendt, der opfyldte QC-kriterier
10. marts 2009
Først opslået (Skøn)
11. marts 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. juli 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juli 2016
Sidst verificeret
1. juli 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NCCTG-N08C1
- NCI-2009-01108 (Registry Identifier: CTRP (Clinical Trials Reporting System))
- CDR0000631962 (Registry Identifier: PDQ (Physician Data Query))
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 .