Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments annual screening, fecal occult blood test, screening colonoscopy, standard follow-up care
Phase phase 3
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date May 2000
End date May 2017
Trial size 4952 participants
Trial identifier NCT00102011, 00-046, MSKCC-00046A, UMN-2003NT062

Summary

RATIONALE: Screening tests, such as colonoscopy and fecal occult blood test, may help doctors find tumor cells early and plan better treatment for colorectal cancer.

PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose screening
Arm
(Experimental)
Participants undergo baseline screening colonoscopy
screening colonoscopy
Patients undergo baseline screening colonoscopy
(Other)
Participants receive standard care
fecal occult blood test
Participants undergo a baseline fecal occult blood test (FOBT)
standard follow-up care
Standard care
(Experimental)
Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
screening colonoscopy
Patients undergo baseline screening colonoscopy
(Active Comparator)
Participants undergo a baseline fecal occult blood test (FOBT). Participants are given individualized recommendations for further surveillance based on the results of the FOBT. Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT.
annual screening
Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT
fecal occult blood test
Participants undergo a baseline fecal occult blood test (FOBT)

Primary Outcomes

Measure
Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy
time frame: 5 years
Burden on endoscopic and clinical resources
time frame: 5 years
Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy
time frame: 5 years
Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy
time frame: 5 years
Level of participation in screening with FOBT-directed colonoscopy vs a single colonoscopy
time frame: 5 years

Eligibility Criteria

Male or female participants from 40 years up to 69 years old.

DISEASE CHARACTERISTICS: - Healthy participants at average risk for developing colorectal cancer - No history of colorectal cancer - No history of familial adenomatous polyposis - More than 5 years since prior flexible sigmoidoscopy - No prior colonoscopy PATIENT CHARACTERISTICS: Age - 50 to 69 (40 to 69 at the Louisiana State University participating site) Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No myocardial infarction within the past year - No congestive heart failure Pulmonary - No chronic obstructive pulmonary disease Gastrointestinal - No history of ulcerative colitis - No history of Crohn's disease - No history of inflammatory bowel disease Other - No serious comorbid condition - No consumption of red meat within 3 days prior to and during FOBT (feasibility study II, arm II only) PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No concurrent chemotherapy other than for nonmelanoma skin cancer Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No vitamin C consumption > 250 mg within 3 days prior to and during fecal occult blood testing (FOBT) (feasibility study II arm II only) - No nonsteroidal anti-inflammatory drugs within 7 days prior to and during FOBT (feasibility study II, arm II only) - No concurrent anticoagulants - No concurrent anticancer therapy except for treatment of nonmelanoma skin cancer

Additional Information

Official title Colonoscopy Screening Trial
Description OBJECTIVES: - Compare the neoplastic outcome of participants at average risk for colorectal cancer who undergo colonoscopy vs annual fecal occult blood tests. - Compare the endoscopic and clinical resources required for these screening methods in these participants. - Compare the benefit-to-harm ratio in participants undergoing these screening methods. - Determine the level of participation of participants undergoing these screening methods. OUTLINE: This is a randomized, two-part, multicenter study. Participants are asked whether they are interested in participating in a randomized controlled trial of colorectal cancer screening. - Screening colonoscopy feasibility study I (accrual completed as of 12/14/2004): Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms. - Arm I: Participants undergo baseline screening colonoscopy. - Arm II: Participants receive standard care. - Screening colonoscopy feasibility study II: Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms. - Arm I: Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy. - Arm II: Participants undergo a baseline fecal occult blood test (FOBT). Participants are given individualized recommendations for further surveillance based on the results of the FOBT. Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT. All participants are followed annually for up to 4 years. PROJECTED ACCRUAL: A total of 1,402 participants (701 per screening arm) have been accrued for feasibility study I within 3 years (accrual completed as of 12/14/2004). An additional 3,550 participants (1,775 per screening arm) will be accrued for feasibility study II within 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.