Combination Chemotherapy Before or After Surgery in Treating Patients With Colorectal Cancer With Liver Metastases That Could Be Removed By Surgery

NCT ID: NCT01189227

Last Updated: 2013-05-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-12-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy work in different ways to kill tumor cells or stop them from growing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether giving combination chemotherapy before and after surgery is more effective than giving combination chemotherapy after surgery.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy before and after surgery to see how well it works compared to giving combination chemotherapy after surgery in treating patients with colorectal cancer with liver metastases that could be removed by surgery.

Detailed Description

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OBJECTIVES:

Primary

* To evaluate the difference in recurrence-free survival (RFS) of patients with potentially resectable hepatic colorectal metastases receiving perioperative (preoperative plus postoperative) adjuvant chemotherapy vs only postoperative adjuvant chemotherapy following liver resection for colorectal metastases.

Secondary

* To compare the proportion of patients between study arms who are R0 or R1 resected, alive, and free of recurrence at 6 months.
* To compare RFS between study arms in the cohort of patients event-free at 6 months.
* To compare overall survival between study arms.
* To evaluate the difference in R0 and combined R0 + R1 resection rates in patients receiving neoadjuvant therapy and those undergoing initial surgical resection.
* To compare the postoperative morbidity profile between study arms.
* To evaluate the safety and toxicity profile of postoperative and perioperative administration of chemotherapy and bevacizumab.

Tertiary

* To evaluate the relationship of baseline circulating tumor cells (CTC) to RFS.
* To evaluate the relationship of baseline CTC to R0 resection.
* To evaluate the relationship of pre-resection CTC in the preoperative therapy group only with RFS and R0 resection.

OUTLINE: This is a multicenter study. Patients are stratified by number of liver metastases (1-3 vs 4+), chemotherapy regimen\* (mFOLFOX6 vs FOLFIRI), and synchronous\*\* primary colorectal cancer (yes vs no). Patients are randomized to 1 of 2 treatment arms.

NOTE: \*Patients who have not received previous oxaliplatin receive mFOLFOX6 chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Patients who have received previous oxaliplatin receive FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.

NOTE: \*\*Synchronous is defined as the detection (by imaging) of suspicious liver metastases within 90 days before or after the date of histologic diagnosis of the primary colon or rectal cancer.

* Arm 1 (postoperative): Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 courses.
* Arm 2 (perioperative): Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 courses. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 courses of mFOLFOX6 or FOLFIRI chemotherapy.

Blood and tumor tissue samples may be collected periodically for correlative studies.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

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Colorectal Cancer Metastatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Postoperative chemotherapy

Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.

Group Type EXPERIMENTAL

Postoperative chemotherapy

Intervention Type PROCEDURE

Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.

Arm 2: Perioperative chemotherapy

Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.

Group Type EXPERIMENTAL

Perioperative chemotherapy

Intervention Type PROCEDURE

Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.

Interventions

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Postoperative chemotherapy

Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.

Intervention Type PROCEDURE

Perioperative chemotherapy

Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* No radiographic evidence of metastases to portal lymph nodes (node \> 1 cm in diameter) unless the node(s) are proven by biopsy to be negative
* No anal, small bowel, or appendiceal carcinoma
* No sarcoma, lymphoma, or carcinoid colorectal malignant diseases
* Within 4 weeks before randomization, the liver metastases must be determined by a hepatic surgeon to be resectable based on meeting both of the following criteria:

* A complete resection can be performed in a single operation
* There are ≥ 2 uninvolved contiguous segments of the liver
* Meets one of the following criteria:

* Primary tumor and regional nodes resected with clear surgical margins and no evidence of extrahepatic disease
* Unresected primary tumor with plans to resect the primary tumor before randomization
* Unresected primary tumor with plans to resect the primary tumor and the liver metastases in a single surgical procedure performed after randomization
* No unresected primary tumor in the colon or rectum with significant symptoms related to obstruction or that will require radiotherapy

PATIENT CHARACTERISTICS:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Life expectancy ≥ 5 years (excluding the diagnosis of metastatic CRC)
* absolute neutrophil count (ANC) ≥ 1,200/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* Total bilirubin ≤ upper limit of normal (ULN)
* aspartate aminotransferase (AST) ≤ 5.0 times ULN
* Alkaline phosphatase ≤ 5.0 times ULN
* Serum creatinine ≤ ULN OR calculated creatinine clearance ≥ 30 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 180 days after completion of study treatment
* Considered a potential candidate for a major hepatic surgical procedure
* No grade 3 or 4 anorexia, grade 3 nausea, or vomiting ≥ grade 2 (per CTCAE v4.0) related to metastatic disease
* No paresthesias, peripheral sensory neuropathy, or peripheral motor neuropathy ≥ grade 2 per Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 (patients with grade 2 neuropathy who will receive FOLFIRI are eligible)
* No uncontrolled high BP defined as systolic BP ≥ 160 mm Hg OR diastolic BP ≥ 100 mm Hg, with or without antihypertensive medication (patients with initial BP elevations are eligible provided initiation or adjustment of BP medication lowers pressure to meet this criteria)
* Documented history of congestive heart failure requiring chronic medical therapy
* No active inflammatory bowel disease
* No active infection or chronic infection requiring chronic suppressive antibiotics
* No known bleeding diathesis or coagulopathy
* No symptomatic interstitial pneumonitis OR definitive evidence of interstitial pneumonitis described on CT scan, MRI, or chest x-ray in asymptomatic patients
* No other malignancies unless the patient is considered to be disease-free and has completed therapy for the malignancy ≥ 1 year ago

* Patients with carcinoma in situ of the cervix, CRC in situ, melanoma in situ, or basal cell or squamous cell carcinoma of the skin diagnosed and treated at any time before study treatment are eligible
* No known Gilbert syndrome
* Not known to be homozygous for the UGT1A1 allele (for patients who will receive FOLFIRI chemotherapy)
* No prior serious hypersensitivity reaction to any of the agents administered as part of study treatment (determination of "serious" is at the investigator's discretion)
* No other serious concurrent medical condition that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to participate in the study, or cause a delay in the initiation of therapy (surgery or chemotherapy) longer than 4 weeks following randomization
* No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
* No pre-existing chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that, in the opinion of the investigator and hepatic surgeon, would limit the patient's ability to undergo hepatic metastasectomy

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No previous hepatic-directed therapy, including hepatic resection and/or ablation, hepatic arterial infusion therapy, or hepatic radiotherapy

* Patients who have only had an incision or excisional biopsy are eligible
* No previous chemotherapy or any other systemic therapy for metastatic colorectal cancer (CRC)
* No prior or concurrent portal vein embolization or other hepatic preconditioning techniques
* At least 30 days since prior investigational products
* No intent to use ablation to treat any hepatic lesion
* No concurrent therapeutic doses of coumadin or equivalent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

NSABP Foundation Inc

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Norman Wolmark, MD

Role: PRINCIPAL_INVESTIGATOR

NSABP Foundation Inc

Locations

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Kaiser Permanente - Deer Valley

Antioch, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Kaiser Permanente - Fremont

Fremont, California, United States

Site Status

Kaiser Permanente Medical Center - Hayward

Hayward, California, United States

Site Status

Kaiser Permanente Medical Center - Oakland

Oakland, California, United States

Site Status

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, United States

Site Status

Kaiser Permanente Medical Center - Redwood City

Redwood City, California, United States

Site Status

Kaiser Permanente Medical Center - Richmond

Richmond, California, United States

Site Status

Kaiser Permanente Medical Center - Roseville

Roseville, California, United States

Site Status

South Sacramento Kaiser-Permanente Medical Center

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, United States

Site Status

Kaiser Permanente Medical Center - San Francisco Geary Campus

San Francisco, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Teresa

San Jose, California, United States

Site Status

Kaiser Foundation Hospital - San Rafael

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, United States

Site Status

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, United States

Site Status

Kaiser Permanente Medical Facility - Stockton

Stockton, California, United States

Site Status

Kaiser Permanente Medical Center - Vacaville

Vacaville, California, United States

Site Status

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, United States

Site Status

Kaiser Permanente Medical Center - Walnut Creek

Walnut Creek, California, United States

Site Status

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

Site Status

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Manchester Memorial Hospital

Manchester, Connecticut, United States

Site Status

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Site Status

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, United States

Site Status

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, United States

Site Status

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, United States

Site Status

Kaiser Permanente - Moanalua Medical Center and Clinic

Honolulu, Hawaii, United States

Site Status

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Elkhart Clinic, LLC

Elkhart, Indiana, United States

Site Status

Howard Community Hospital

Kokomo, Indiana, United States

Site Status

Reid Hospital & Health Care Services

Richmond, Indiana, United States

Site Status

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Site Status

Michiana Hematology-Oncology, PC - South Bend

South Bend, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status

Medical Oncology and Hematology Associates - West Des Moines

Clive, Iowa, United States

Site Status

Mercy Cancer Center - West Lakes

Clive, Iowa, United States

Site Status

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Site Status

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, United States

Site Status

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Site Status

McCreery Cancer Center at Ottumwa Regional

Ottumwa, Iowa, United States

Site Status

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Site Status

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

Site Status

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Liberal

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Saint Luke's Hospital - South

Overland Park, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

CCOP - Kansas City

Prairie Village, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, United States

Site Status

Associates in Womens Health, PA - North Review

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, United States

Site Status

CCOP - Wichita

Wichita, Kansas, United States

Site Status

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, United States

Site Status

Central Baptist Hospital

Lexington, Kentucky, United States

Site Status

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, United States

Site Status

Ochsner Health Center - Bluebonnet

Baton Rouge, Louisiana, United States

Site Status

Ochsner Health Center - Covington

Covington, Louisiana, United States

Site Status

CCOP - Ochsner

New Orleans, Louisiana, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

Baltimore, Maryland, United States

Site Status

Union Hospital of Cecil County

Elkton MD, Maryland, United States

Site Status

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Site Status

Berkshire Hematology Oncology, PC

Pittsfield, Massachusetts, United States

Site Status

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, United States

Site Status

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

Site Status

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

Site Status

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, United States

Site Status

Foote Memorial Hospital

Jackson, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

Breslin Cancer Center at Ingham Regional Medical Center

Lansing, Michigan, United States

Site Status

Sparrow Regional Cancer Center

Lansing, Michigan, United States

Site Status

St. Mary Mercy Hospital

Livonia, Michigan, United States

Site Status

Mercy Memorial Hospital - Monroe

Monroe, Michigan, United States

Site Status

St. Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, United States

Site Status

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, United States

Site Status

Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, United States

Site Status

Providence Cancer Institute at Providence Hospital - Southfield Campus

Southfield, Michigan, United States

Site Status

St. John Macomb Hospital

Warren, Michigan, United States

Site Status

St. Joseph's Medical Center

Brainerd, Minnesota, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

CCOP - Duluth

Duluth, Minnesota, United States

Site Status

St. Luke's Hospital Cancer Care Center

Duluth, Minnesota, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Fergus Falls Medical Group, PA

Fergus Falls, Minnesota, United States

Site Status

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, United States

Site Status

Hutchinson Area Health Care

Hutchinson, Minnesota, United States

Site Status

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, United States

Site Status

Minnesota Oncology Hematology, PA - Maplewood

Maplewood, Minnesota, United States

Site Status

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, United States

Site Status

Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, United States

Site Status

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

Site Status

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

St. Francis Cancer Center at St. Francis Medical Center

Shakopee, Minnesota, United States

Site Status

Lakeview Hospital

Stillwater, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Willmar Cancer Center at Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status

Minnesota Oncology Hematology, PA - Woodbury

Woodbury, Minnesota, United States

Site Status

Goldschmidt Cancer Center

Jefferson City, Missouri, United States

Site Status

Saint Luke's Cancer Institute at Saint Luke's Hospital

Kansas City, Missouri, United States

Site Status

St. Joseph Medical Center

Kansas City, Missouri, United States

Site Status

North Kansas City Hospital

Kansas City, Missouri, United States

Site Status

Parvin Radiation Oncology

Kansas City, Missouri, United States

Site Status

Heartland Hematology Oncology Associates, Incorporated

Kansas City, Missouri, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, United States

Site Status

Liberty Hospital

Liberty, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States

Site Status

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

Site Status

Saint Louis University Cancer Center

St Louis, Missouri, United States

Site Status

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Site Status

Missouri Baptist Cancer Center

St Louis, Missouri, United States

Site Status

Comprehensive Cancer Care, PC

St Louis, Missouri, United States

Site Status

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Site Status

St. Vincent Healthcare Cancer Care Services

Billings, Montana, United States

Site Status

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, United States

Site Status

Billings Clinic - Downtown

Billings, Montana, United States

Site Status

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

Site Status

St. James Healthcare Cancer Care

Butte, Montana, United States

Site Status

Great Falls Clinic - Main Facility

Great Falls, Montana, United States

Site Status

Sletten Cancer Institute at Benefis Healthcare

Great Falls, Montana, United States

Site Status

St. Peter's Hospital

Helena, Montana, United States

Site Status

Glacier Oncology, PLLC

Kalispell, Montana, United States

Site Status

Kalispell Medical Oncology at KRMC

Kalispell, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, United States

Site Status

Cancer Resource Center - Lincoln

Lincoln, Nebraska, United States

Site Status

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

Site Status

Immanuel Medical Center

Omaha, Nebraska, United States

Site Status

Alegant Health Cancer Center at Bergan Mercy Medical Center

Omaha, Nebraska, United States

Site Status

Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Charles R. Wood Cancer Center at Glens Falls Hospital

Glens Falls, New York, United States

Site Status

NYU Cancer Institute at New York University Medical Center

New York, New York, United States

Site Status

Nalitt Cancer Institute at Staten Island University Hospital

Staten Island, New York, United States

Site Status

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, United States

Site Status

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, United States

Site Status

Kinston Medical Specialists

Kinston, North Carolina, United States

Site Status

Iredell Memorial Hospital

Statesville, North Carolina, United States

Site Status

Forsyth Regional Cancer Center at Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

CCOP - MeritCare Hospital

Fargo, North Dakota, United States

Site Status

Mary Rutan Hospital

Bellefontaine, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, United States

Site Status

CCOP - Columbus

Columbus, Ohio, United States

Site Status

Grant Medical Center Cancer Care

Columbus, Ohio, United States

Site Status

Mount Carmel Health - West Hospital

Columbus, Ohio, United States

Site Status

Doctors Hospital at Ohio Health

Columbus, Ohio, United States

Site Status

Grandview Hospital

Dayton, Ohio, United States

Site Status

Good Samaritan Hospital

Dayton, Ohio, United States

Site Status

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, United States

Site Status

CCOP - Dayton

Dayton, Ohio, United States

Site Status

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status

Community Cancer Center

Elyria, Ohio, United States

Site Status

Hematology Oncology Center

Elyria, Ohio, United States

Site Status

Blanchard Valley Medical Associates

Findlay, Ohio, United States

Site Status

Middletown Regional Hospital

Franklin, Ohio, United States

Site Status

Wayne Hospital

Greenville, Ohio, United States

Site Status

Charles F. Kettering Memorial Hospital

Kettering, Ohio, United States

Site Status

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status

Lima Memorial Hospital

Lima, Ohio, United States

Site Status

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, United States

Site Status

Fisher-Titus Medical Center

Norwalk, Ohio, United States

Site Status

St. Charles Mercy Hospital

Oregon, Ohio, United States

Site Status

North Coast Cancer Care, Incorporated

Sandusky, Ohio, United States

Site Status

Community Hospital of Springfield and Clark County

Springfield, Ohio, United States

Site Status

Flower Hospital Cancer Center

Sylvania, Ohio, United States

Site Status

Mercy Hospital of Tiffin

Tiffin, Ohio, United States

Site Status

Toledo Hospital

Toledo, Ohio, United States

Site Status

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

Medical University of Ohio Cancer Center

Toledo, Ohio, United States

Site Status

CCOP - Toledo Community Hospital

Toledo, Ohio, United States

Site Status

St. Anne Mercy Hospital

Toledo, Ohio, United States

Site Status

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, United States

Site Status

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, United States

Site Status

Fulton County Health Center

Wauseon, Ohio, United States

Site Status

Mount Carmel St. Ann's Cancer Center

Westerville, Ohio, United States

Site Status

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, United States

Site Status

Genesis - Good Samaritan Hospital

Zanesville, Ohio, United States

Site Status

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Site Status

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, United States

Site Status

Butler Memorial Hospital

Butler, Pennsylvania, United States

Site Status

Riddle Memorial Hospital Cancer Center

Media, Pennsylvania, United States

Site Status

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Allegheny Cancer Center at Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

Site Status

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, United States

Site Status

Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center

Upland, Pennsylvania, United States

Site Status

Bon Secours St. Francis Health System

Greenville, South Carolina, United States

Site Status

CCOP - Greenville

Greenville, South Carolina, United States

Site Status

Self Regional Cancer Center at Self Regional Medical Center

Greenwood, South Carolina, United States

Site Status

Medical X-Ray Center, PC

Sioux Falls, South Dakota, United States

Site Status

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Site Status

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Site Status

Parkland Memorial Hospital

Dallas, Texas, United States

Site Status

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Site Status

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

Site Status

Sandra L. Maxwell Cancer Center

Cedar City, Utah, United States

Site Status

Logan Regional Hospital

Logan, Utah, United States

Site Status

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

Ogden, Utah, United States

Site Status

Utah Valley Regional Medical Center - Provo

Provo, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Dixie Regional Medical Center - East Campus

St. George, Utah, United States

Site Status

Danville Regional Medical Center

Danville, Virginia, United States

Site Status

Fredericksburg Oncology, Incorporated

Fredericksburg, Virginia, United States

Site Status

Overlake Cancer Center at Overlake Hospital Medical Center

Bellevue, Washington, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Group Health Central Hospital

Seattle, Washington, United States

Site Status

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

Site Status

Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

Parkersburg, West Virginia, United States

Site Status

Marshfield Clinic - Chippewa Center

Chippewa Falls, Wisconsin, United States

Site Status

Marshfield Clinic Cancer Care at Regional Cancer Center

Eau Claire, Wisconsin, United States

Site Status

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States

Site Status

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Site Status

Marshfield Clinic - Lakeland Center

Minocqua, Wisconsin, United States

Site Status

Ministry Medical Group at Saint Mary's Hospital

Rhinelander, Wisconsin, United States

Site Status

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, United States

Site Status

Marshfield Clinic at Saint Michael's Hospital

Stevens Point, Wisconsin, United States

Site Status

Marshfield Clinic - Weston Center

Weston, Wisconsin, United States

Site Status

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, United States

Site Status

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NSABP-C-11

Identifier Type: -

Identifier Source: secondary_id

NSABP C-11

Identifier Type: -

Identifier Source: org_study_id

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