As it has been mentioned before, there are clinical trials for any and all parts of the cancer journey, as well as trials for those with average risk for developing colorectal cancer, or those with a higher risk for developing cancer.

Learning about and educating ourselves about clinical trials can be helpful in our advocacy for better health for everyone, not just patients with colorectal cancer.

Five- or Ten-Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps (FORTE)

NCT05080673

What is the best timing for a repeat colonoscopy for people with one or two small benign polyps removed during colonoscopy? There is not an optimal answer for that –yet.

The randomized FORTE/NRG-CC005 trial (NCT05080673) is looking to answer that question by evaluating different frequency of surveillance colonoscopy in individuals with a first-time presentation and removal of one to two small, benign polyps. FORTE stands for “Five- or Ten-Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps,” and it is a study sponsored by the NCI.

This study will measure and compare the colorectal cancer (CRC) incidence rates in the two study groups. If the cancer rates are similar to each other, then a 5-year follow-up surveillance colonoscopy exam may not be needed. Additional outcome measures include incidence of advanced adenoma, CRC mortality, and incidence of stage III to IV CRC, all at 10 years.

The study is expected to enroll 9500 participants ages 50 to 70 years; approximately 4750 individuals will be enrolled in each study group.

This is a clinical trial for those who are not facing CRC.

Those who have a prior history of CRC are excluded from enrollment on FORTE. The trial is open to participants with just a first-time diagnosis of one or two non-advanced tubular adenomas in a colonoscopy, even to those who had that colonoscopy within four years prior to the start of this trial.

Why would one want to participate in this trial? What would be the benefit? As participants, patients will be followed up closely, since they are being asked to provide blood, stool, and other tissues for additional studies to help the researchers better understand how colorectal cancer develops from a polyp. The trial’s findings will guide clinicians in optimizing surveillance strategies, potentially reducing unnecessary procedures and improving patient outcomes, for all the community.

FORTE is being conducted through a collaboration with the NCI Community Oncology Research Program and the National Clinical Trials Network. NRG Oncology, which is funded by grants from the NCI, will head the trial alongside the Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, and SWOG.

For more details, you can visit the FORTE study webpage where you will find a video and plain language information about this clinical trial. To follow updates on social media: X / Twitter (@fortestudy) and Instagram (@fortestudy).

ASPIRED-XT: ASPirin Intervention for the REDuction of Colorectal Cancer Risk –EXTension

NCT05056896

The ASPIRED-XT trial is a double-blind, placebo-controlled, randomized clinical trial that takes place at Massachusetts General Hospital (Boston, Mass.). Researchers aim to measure the effects of daily low-dose aspirin on various biomarkers associated with colorectal cancer. The study focuses on understanding how aspirin impacts these biomarkers and whether age influences these effects. It is a direct extension of an earlier study: the ASPIRED trial.

Aspirin, a non-steroidal anti-inflammatory drug (NSAID), has shown promise in reducing the risk of colorectal polyps and cancer, but the exact mechanism by which aspirin prevents colorectal cancer remains uncertain. This trial may help researchers understand the mechanisms of aspirin’s anti-cancer effect, which may lead to the discovery of new specific characteristics (markers) that can be used to select patients for aspirin treatment.

Participants must have undergone a colonoscopy within the past nine months, during which at least one polyp was removed. Since polyps are a risk factor for colorectal cancer, the study aims to determine whether daily low-dose aspirin can serve as an effective preventive measure. Approximately 160 people are expected to participate during this 3-month-long research study; Half of the participants (80) will be randomly assigned to receive a daily low-dose aspirin (81 mg), and the other half (80) will receive a daily placebo (no aspirin) capsule.

Participants may be contacted periodically after the study (no more than one to two times annually) for up to 10 years to follow-up on additional information including any continued aspirin use or follow-up colonoscopy results.

Once a month, Maia Walker and Manju George spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!

You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.