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AzTrials

Colorectal CancerPhase 3NCT00002527

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

A Phase 3 study testing aspirin in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 42 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 74 years
Conditions the study is for
Colorectal Cancer
What is being tested?
aspirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
635 participants
Where
42 sitesin 2 countries
Study dates
May 1993to Jan 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

42 sites in 2 countries.

42 sites in 2 countries

United States41 sites

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Quain & Ramstad Clinic, P.C.

    Bismarck, North Dakota, 58501

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • CCOP - Geisinger Clinical and Medical Center

    Danville, Pennsylvania, 17822-2001

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 10309-1016

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • Altru Health Systems

    Grand Forks, North Dakota, 58201

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • University of Tennessee, Memphis Cancer Center

    Memphis, Tennessee, 38163

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10021

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57709

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CentraCare Clinic

    Saint Cloud, Minnesota, 56303

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94115-0128

  • CCOP - Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • Siouxland Hematology-Oncology

    Sioux City, Iowa, 51101-1733

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57105-1080

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Canada1 site

  • Saskatchewan Cancer Agency

    Regina, Saskatchewan, S4S 6X3

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
aspirin, placebo
Keywords
colon cancer, rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00002527
Study groupRoleWhat they receive
AspirinExperimental325 mg/day PO
Receives: Drug: aspirin
PlaceboPlacebo comparatorNot described
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in size of tumors

    Measured: Up to 4 years

  2. Reduction in number of tumors

    Measured: Up to 4 years

  3. Disease free survival

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2004 (estimated)
  2. Study startMay 1993
  3. Primary completionMar 2003
  4. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
635 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002527
Sponsor's protocol ID
CALGB-9270
Other IDs
CLB-9270, E-C9270, NCCTG-949251, NCI-P93-0048, CDR0000078380
Status last verified
Jul 2016
First submitted
1 Nov 1999
Last updated
4 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Sandler RS, Halabi S, Baron JA, Budinger S, Paskett E, Keresztes R, Petrelli N, Pipas JM, Karp DD, Loprinzi CL, Steinbach G, Schilsky R. A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer. N Engl J Med. 2003 Mar 6;348(10):883-90. doi: 10.1056/NEJMoa021633.

    PubMed 12621132

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aspirin in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 42 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in size of tumors (time frame: Up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002527, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.

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