Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Screening Active 50 to 69 (40 to 69 at LSU site) NCI MSKCC-00046A NCT00102011, UMN-2003NT062

Objectives

1. Compare the neoplastic outcome of participants at average risk for colorectal cancer who undergo colonoscopy vs annual fecal occult blood tests.
2. Compare the endoscopic and clinical resources required for these screening methods in these participants.
3. Compare the benefit-to-harm ratio in participants undergoing these screening methods.
4. Determine the level of participation of participants undergoing these screening methods.

Entry Criteria

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

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

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)

Expected Enrollment

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.

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Sidney Winawer, MD, Protocol chair		Ph: 212-639-7675; 800-525-2225 Email: winawers@mskcc.org

U.S.A.
Louisiana
	Shreveport
	Feist-Weiller Cancer Center at Louisiana State University Health Sciences
		Clinical Trials Office - Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Ph:  318-813-1412
Minnesota
	Minneapolis
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
Washington
	Seattle
	Group Health Central Hospital
		Clinical Trials Office - Group Health Central Hospital	Ph:  206-287-2900

Registry Information
Official Title		Colonoscopy Screening Trial
Trial Start Date		2000-05-01
Trial Completion Date		2010-05-03 (estimated)
Registered in ClinicalTrials.gov		NCT00102011
Date Submitted to PDQ		2004-12-29
Information Last Verified		2008-12-14
NCI Grant/Contract Number		P30-CA08748