Health Trials

About this trial

This trial examines 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.

Eligibility criteria

Qualifiers

The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.

Participants greater than or equal to 45 and less than 70 years of age at the time of colonoscopy.

Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 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.

Disqualifiers

• Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps/adenomas excluding those found on the qualifying colonoscopy.

Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size.

Traditional serrated adenomas found on the qualifying colonoscopy.

Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy.

Trial design

Treatments tested in this trial

  • 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

Treatment groups

9,500 Participants
are divided into 2 treatment groups

Locations

485
Puerto Rico
Cancer Center-Metro Medical Center Bayamon00959-5060, Bayamón Puerto Rico
Puerto Rico Hematology Oncology Group00961, Bayamón Puerto Rico
HIMA San Pablo Oncologic Hospital00726, Caguas Puerto Rico
Pan American Center for Oncology Trials LLC - Dorado00646, Dorado Puerto Rico

Sponsors and collaborators

NRG Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov