Aspirin in Treating Patients With Colorectal Cancer That Has Been Surgically Removed

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00002527

Collaborator

National Cancer Institute (NCI) (NIH)

635

Enrollment

Locations

Arms

152

Duration (Months)

15.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: aspirin Other: placebo	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

635 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Colorectal Adenoma Chemoprevention Trial Using Aspirin: A Phase III Study

Study Start Date :

May 1, 1993

Actual Primary Completion Date :

Mar 1, 2003

Actual Study Completion Date :

Jan 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aspirin 325 mg/day PO	Drug: aspirin
Placebo Comparator: Placebo	Other: placebo

Arm

Intervention/Treatment

Experimental: Aspirin

325 mg/day PO

Drug: aspirin

Placebo Comparator: Placebo

Other: placebo

Outcome Measures

Primary Outcome Measures

Reduction in size of tumors [Up to 4 years]
Reduction in number of tumors [Up to 4 years]
Disease free survival [Up to 4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94115-0128
3	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
4	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637
5	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
6	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
7	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
8	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	10309-1016
9	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
10	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
11	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
12	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
13	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
14	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
15	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
16	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
17	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
18	CentraCare Clinic	Saint Cloud	Minnesota	United States	56303
19	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri	United States	65203
20	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
21	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68131
22	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
23	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756
24	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
25	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
26	New York Presbyterian Hospital - Cornell Campus	New York	New York	United States	10021
27	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
28	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
29	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
30	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157-1082
31	Quain & Ramstad Clinic, P.C.	Bismarck	North Dakota	United States	58501
32	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
33	Altru Health Systems	Grand Forks	North Dakota	United States	58201
34	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
35	CCOP - Geisinger Clinical and Medical Center	Danville	Pennsylvania	United States	17822-2001
36	Rhode Island Hospital	Providence	Rhode Island	United States	02903
37	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
38	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57105-1080
39	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee	United States	38163
40	Vermont Cancer Center	Burlington	Vermont	United States	05401-3498
41	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037
42	Saskatchewan Cancer Agency	Regina	Saskatchewan	Canada	S4S 6X3

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Investigators

Study Chair: Robert Sandler, MD, MPH, UNC Lineberger Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT00002527

Other Study ID Numbers:

CALGB-9270
CLB-9270
E-C9270
NCCTG-949251
NCI-P93-0048
CDR0000078380

First Posted:

Aug 31, 2004

Last Update Posted:

Jul 4, 2016

Last Verified:

Jul 1, 2016

Keywords provided by Alliance for Clinical Trials in Oncology

colon cancer

rectal cancer

Additional relevant MeSH terms:

Colorectal Neoplasms

Aspirin

Study Results

No Results Posted as of Jul 4, 2016