Aspirin in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
Colorectal Adenoma Chemoprevention Trial Using Aspirin: A Phase III Study
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of aspirin may be an effective way to prevent the recurrence of polyps in colorectal cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of aspirin in treating patients who have stage I, stage II, or stage III colorectal cancer that has been surgically removed.
연구 개요
상세 설명
OBJECTIVES: I. Determine whether aspirin administered at a dose of 325 mg/day will decrease the number and size of new adenomas in patients with Dukes' A/B1/B2/C colorectal cancer who have undergone curative surgical resection. II. Assess whether this dose of aspirin will increase disease-free survival in these patients.
OUTLINE: Randomized, double-blind study. Arm I: Chemoprevention. Enteric-coated Aspirin, ASA, NSC-27223. Arm II: Control. Placebo, PLCB.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
Arizona
-
Scottsdale, Arizona, 미국, 85259-5404
- CCOP - Scottsdale Oncology Program
-
-
California
-
San Francisco, California, 미국, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
-
-
Florida
-
Miami Beach, Florida, 미국, 33140
- CCOP - Mount Sinai Medical Center
-
-
Illinois
-
Chicago, Illinois, 미국, 60637
- University of Chicago Cancer Research Center
-
Peoria, Illinois, 미국, 61602
- CCOP - Illinois Oncology Research Association
-
Urbana, Illinois, 미국, 61801
- CCOP - Carle Cancer Center
-
-
Iowa
-
Cedar Rapids, Iowa, 미국, 52403-1206
- CCOP - Cedar Rapids Oncology Project
-
Des Moines, Iowa, 미국, 10309-1016
- CCOP - Iowa Oncology Research Association
-
Iowa City, Iowa, 미국, 52242
- University of Iowa Hospitals and Clinics
-
Sioux City, Iowa, 미국, 51101-1733
- Siouxland Hematology-Oncology
-
-
Louisiana
-
New Orleans, Louisiana, 미국, 70121
- CCOP - Ochsner
-
-
Maryland
-
Baltimore, Maryland, 미국, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital Cancer Center
-
Worcester, Massachusetts, 미국, 01655
- University of Massachusetts Memorial Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48106
- CCOP - Ann Arbor Regional
-
-
Minnesota
-
Minneapolis, Minnesota, 미국, 55455
- University of Minnesota Cancer Center
-
Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
-
Saint Cloud, Minnesota, 미국, 56303
- CentraCare Clinic
-
-
Missouri
-
Columbia, Missouri, 미국, 65203
- Ellis Fischel Cancer Center - Columbia
-
Saint Louis, Missouri, 미국, 63110
- Barnes-Jewish Hospital
-
-
Nebraska
-
Omaha, Nebraska, 미국, 68131
- CCOP - Missouri Valley Cancer Consortium
-
-
Nevada
-
Las Vegas, Nevada, 미국, 89106
- CCOP - Southern Nevada Cancer Research Foundation
-
-
New Hampshire
-
Lebanon, New Hampshire, 미국, 03756
- Norris Cotton Cancer Center
-
-
New York
-
Buffalo, New York, 미국, 14263-0001
- Roswell Park Cancer Institute
-
Manhasset, New York, 미국, 11030
- CCOP - North Shore University Hospital
-
New York, New York, 미국, 10021
- New York Presbyterian Hospital - Cornell Campus
-
Syracuse, New York, 미국, 13210
- State University of New York - Upstate Medical University
-
-
North Carolina
-
Chapel Hill, North Carolina, 미국, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
-
Winston-Salem, North Carolina, 미국, 27104-4241
- CCOP - Southeast Cancer Control Consortium
-
Winston-Salem, North Carolina, 미국, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
-
-
North Dakota
-
Bismarck, North Dakota, 미국, 58501
- Quain & Ramstad Clinic, P.C.
-
Fargo, North Dakota, 미국, 58122
- CCOP - Merit Care Hospital
-
Grand Forks, North Dakota, 미국, 58201
- Altru Health Systems
-
-
Ohio
-
Toledo, Ohio, 미국, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
-
-
Pennsylvania
-
Danville, Pennsylvania, 미국, 17822-2001
- CCOP - Geisinger Clinical and Medical Center
-
-
Rhode Island
-
Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital
-
-
South Dakota
-
Rapid City, South Dakota, 미국, 57709
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, 미국, 57105-1080
- CCOP - Sioux Community Cancer Consortium
-
-
Tennessee
-
Memphis, Tennessee, 미국, 38163
- University of Tennessee, Memphis Cancer Center
-
-
Vermont
-
Burlington, Vermont, 미국, 05401-3498
- Vermont Cancer Center
-
-
Virginia
-
Richmond, Virginia, 미국, 23298-0037
- MBCCOP - Massey Cancer Center
-
-
-
-
Saskatchewan
-
Regina, Saskatchewan, 캐나다, S4S 6X3
- Saskatchewan Cancer Agency
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS: Histologically documented colorectal cancer that has been curatively resected, including: Dukes' A/B1 (T1-2, N0, M0) Dukes' B2/C (T3, N0, M0 and any T, N1, M0) disease-free more than 5 years post-resection Colonoscopy to the cecum (or small bowel anastomosis) with removal of all polyps required within 4 months of entry Preparation must be adequate to visualize mucosa and discern the presence of no further polyps No familial polyposis (more than 100 polyps at time of resection) No history of inflammatory bowel disease including ulcerative colitis or Crohn's disease
PATIENT CHARACTERISTICS: Age: 30 to under 75 Performance status: Physician's assessment of good general health required Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No NYHA class III/IV status No history of angina No history of MI No history of stroke or TIAs No peripheral vascular disease No bleeding diathesis including hemorrhagic stroke No prophylactic aspirin for cardiovascular disease Other: No documented peptic ulcer disease within past 15 years No aspirin sensitivity including: Aspirin-induced asthma Bronchial hyper-reactivity Urticaria Angioedema No requirement for sodium warfarin or other anticoagulant No frequent (greater than 36 times/year) NSAID use within the past 5 years No recurrent arthritis or other musculoskeletal problems No narcotic or alcohol dependency (unless there has been at least a 6-month period of abstinence) No prior or concurrent malignancy within 5 years (including metastases) except nonmelanomatous skin cancer No pregnant or nursing women Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY: No concurrent enrollment in a colon cancer treatment trial or other chemoprevention trial Biologic therapy: At least 6 months since immunosuppressive therapy (i.e., azathioprine, methotrexate, cyclosporine) Chemotherapy: Prior chemotherapy allowed for patients with Dukes' B2/C colorectal cancer No concurrent chemotherapy Endocrine therapy: Prior non-immunosuppressive steroid treatment allowed Radiotherapy: Prior radiotherapy allowed for patients with Dukes' B2/C colorectal cancer No concurrent radiotherapy Surgery: Curative resection required
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
무질병 생존
기간: 최대 4년
|
최대 4년
|
|
Reduction in size of tumors
기간: Up to 4 years
|
Up to 4 years
|
|
Reduction in number of tumors
기간: Up to 4 years
|
Up to 4 years
|
공동 작업자 및 조사자
수사관
- 연구 의자: Robert Sandler, MD, MPH, UNC Lineberger Comprehensive Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CALGB-9270
- CLB-9270
- E-C9270
- NCCTG-949251
- NCI-P93-0048
- CDR0000078380 (레지스트리 식별자: NCI Physician Data Query)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .