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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

Status
Active
Cancer Type
Colon/Rectal Cancer
Trial Phase
Phase III
Eligibility
50 - 70 Years, Male and Female
Study Type
Health services research
NCT ID
NCT05080673
Protocol IDs
NRG-CC005 (primary)
NRG-CC005
NRG-CC005
NCI-2020-00733
Study Sponsor
NRG Oncology

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.

ARM 2: Patients undergo repeat colonoscopy at 10 years after benign polyp removal.

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

Eligibility

  1. The participant must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  2. Participants >= 50 and >= 70 years of age at the time of randomization
  3. Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (< 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years prior to randomization * Sessile serrated polyps/adenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas
  4. Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization
  5. Complete excision of all observed polyps in qualifying colonoscopy
  6. Participants must be able to read or understand English or Spanish
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.