A Study to Examine How Often (Every 5 Years or 10 Years) a Colonoscopy Should be Done in Participants Who Had One or Two Small Growths of Tissue Removed from Their Colon

Active:	Yes
Cancer Type:	Colon/Rectal Cancer	NCT ID:	NCT05080673
Trial Phases:	Phase III	Protocol IDs:	NRG-CC005 (primary) NRG-CC005 NRG-CC005 NCI-2020-00733
Eligibility:	50 - 70 Years, Male and Female	Study Type:	Prevention
Study Sponsor:	NRG Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT05080673

Summary

This phase III trial compares how often (every 5 and 10 years versus every 10 years) a colonoscopy should be done in participants who had one or two non-cancerous (benign) small growth of tissue (polyps) removed from their colon. The usual approach is to have a repeat colonoscopy in 5 to 10 years. The goal of this study is to find the best timing for a repeat colonoscopy for patients with 1 or 2 small benign polyps removed during colonoscopy.

Objectives

PRIMARY OBJECTIVE:
I. To examine colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

PRE-DEFINED EXPLORATORY OBJECTIVES:
I. To examine advanced adenoma incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.
II. To examine colorectal cancer mortality in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.
III. To examine stage III-IV colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

EXPLORATORY OBJECTIVE:
I. Collection of blood, stool, and tissue samples for purposes of the NRG-CC005 study and for future unspecified research.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients undergo repeat colonoscopy at 5 and 10 years after benign polyp removal. Patients also undergo collection of blood, stool, and polyp tissue on study.

ARM 2: Patients undergo repeat colonoscopy at 10 years after benign polyp removal. Patients also undergo collection of blood, stool, and polyp tissue on study.

Patients have the option to be followed for up to 30 years after joining the study.

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