5-Year vs. 10-Year Colonoscopy for Colorectal Cancer Prevention

(FORTE Trial)

Recruiting at 435 trial locations

Overseen By Director, Department of Regulatory Affairs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NRG Oncology

Disqualifiers: Colorectal cancer, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

9500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for guidance.

What data supports the effectiveness of the treatment 5-year and 10-Year Surveillance Colonoscopy for colorectal cancer prevention?

The research suggests that a 10-year colonoscopy after a negative result does not significantly reduce early colorectal cancer risk, indicating the need for further studies. However, surveillance colonoscopy is generally aimed at reducing cancer incidence by removing growths and detecting cancer early, especially in those with higher risk factors. ^{1 2 3 4 5}

Is colonoscopy generally safe for humans?

Colonoscopy is generally considered safe, but like any medical procedure, it can have risks. Some studies have looked at adverse events (unwanted side effects) during long-term colonoscopy programs, but detailed safety data is limited. ^{1 2 5 6 7}

How does the 5-year vs. 10-year colonoscopy treatment for colorectal cancer prevention differ from other treatments?

This treatment is unique because it compares the effectiveness of having a colonoscopy every 5 years versus every 10 years for preventing colorectal cancer, focusing on the timing of surveillance rather than a new drug or procedure. ^{1 2 3 4 7}

What is the purpose of this trial?

This trial aims to determine the best schedule for preventing small, non-dangerous growths in the colon from turning into cancer by regularly checking and removing them.

Research Team

Robert Schoen, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for people who've had a colonoscopy within the last 4 years, found to have 1-2 small non-advanced adenomas, and removed them completely. They must be able to understand English or Spanish and give informed consent. It's not for those with high genetic risk of colorectal cancer, inflammatory bowel disease, large hyperplastic polyps, previous significant cancers (except certain skin cancers), or life expectancy less than 10 years.

Inclusion Criteria

All polyps found during my colonoscopy were completely removed.

I had a thorough colonoscopy with clear views and good cleansing within the last 4 years.

I was diagnosed with 1-2 small, non-advanced tubular adenomas less than 4 years ago.

Exclusion Criteria

I have had surgery to remove part or all of my colon.

A close family member had colorectal cancer at 60 or older, or two relatives had it at any age.

I have had a large growth in my colon before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualifying Colonoscopy

Participants undergo a qualifying colonoscopy to identify 1-2 non-advanced adenomas

1 day

1 visit (in-person)

Surveillance Colonoscopy

Participants are randomized to undergo surveillance colonoscopy at either 5 years and 10 years or only at 10 years

10 years

2 visits (in-person) for 5-year and 10-year group, 1 visit (in-person) for 10-year group

Follow-up

Participants are monitored for incidence of advanced adenoma and colorectal cancer

10 years

Treatment Details

Interventions

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

Trial Overview The study is testing if it's just as effective to do follow-up colonoscopies at ten-year intervals instead of five after finding and removing small benign polyps. Participants are randomly placed into two groups: one will have a check-up at five years and another only at ten years.

Participant Groups

Group I: Arm 2 Experimental Treatment 1 Intervention

10-Year Surveillance Colonoscopy after Qualifying Colonoscopy

Group II: Arm 1 Experimental Treatment 1 Intervention

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

5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy is already approved in United States, European Union for the following indications:

Approved in United States as Surveillance Colonoscopy for:

• Colorectal Cancer Screening
• Follow-up after adenomatous polyp removal

Approved in European Union as Surveillance Colonoscopy for:

• Colorectal Cancer Screening
• Follow-up after adenomatous polyp removal

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 13,350 matched pairs of individuals aged 50-74 with a previous negative colonoscopy, undergoing a repeat colonoscopy 10 years later did not significantly reduce the risk of early incident colorectal cancer (CRC).

The cumulative probability of developing CRC was similar between those who had a repeat colonoscopy (0.70%) and those who did not (0.77%), suggesting that the current recommendation for 10-year re-screening may need further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of colorectal cancer after a negative colonoscopy in low-to-moderate risk individuals: impact of a 10-year colonoscopy. Murthy, SK., Dubé, C., Rostom, A., et al.[2018]

In a study of 3,121 asymptomatic subjects aged 50 to 75, those with baseline neoplasia had a significantly higher risk of developing advanced neoplasia within 5.5 years, with relative risks ranging from 1.92 to 6.87 depending on the type and size of adenomas found during initial screening.

Patients with 1 or 2 tubular adenomas smaller than 10 mm were identified as a low-risk group for developing serious lesions, suggesting that not all neoplasia findings carry the same risk for future complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year colon surveillance after screening colonoscopy. Lieberman, DA., Weiss, DG., Harford, WV., et al.[2022]

Patients with nonadvanced adenomas can safely extend their postpolypectomy colonoscopy surveillance intervals beyond 5 years, as their risk of advanced adenoma recurrence is similar whether they are screened at 5 years or 6 to 10 years.

Those with an advanced adenoma at their initial colonoscopy have a significantly higher risk of finding another advanced adenoma at follow-up (26% at 5 years), indicating they should have their next colonoscopy sooner than 5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colonoscopy surveillance after polypectomy may be extended beyond five years. Miller, HL., Mukherjee, R., Tian, J., et al.[2022]

In a study of 3121 asymptomatic veterans followed for 10 years, those with baseline colorectal cancer had the highest 10-year risk of advanced neoplasia at 43.7%, while those with 1-2 small adenomas had a much lower risk of 6.3%.

The findings suggest that individuals with only 1 or 2 small adenomas at baseline have a low risk of developing advanced neoplasia over 10 years, indicating that alternative surveillance strategies could be considered for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline Colonoscopy Findings Associated With 10-Year Outcomes in a Screening Cohort Undergoing Colonoscopy Surveillance. Lieberman, D., Sullivan, BA., Hauser, ER., et al.[2020]

Surveillance colonoscopy is essential for reducing colorectal cancer (CRC) incidence and mortality, but current practices are based on moderate to low-quality evidence, leading to suboptimal use of resources.

Patients with low-risk adenomas (1-2 adenomas smaller than 10 mm) may not need surveillance, while those with 3 or more adenomas or any adenoma larger than 10 mm should have surveillance every 3 years, highlighting the need for more rigorous studies to optimize follow-up strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surveillance after colorectal polyp removal. Jover, R., Dekker, E.[2022]

In a study of 3121 asymptomatic veterans who underwent colonoscopy screening, adverse events occurred in only 2.8% of follow-up examinations, indicating that long-term colonoscopy screening is generally safe.

Serious cardiopulmonary events were the most common major complications, and a history of prior colonoscopic adverse events significantly increased the risk of future complications, suggesting the importance of assessing patients' medical histories before follow-up procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of colonoscopy adverse events in the prospective Cooperative Studies Program no. 380 colorectal cancer screening and surveillance cohort. Kobe, EA., Sullivan, BA., Qin, X., et al.[2023]

A flexible sigmoidoscopy screening program for colorectal cancer in asymptomatic average-risk individuals showed that 14% of initial screenings detected at least one adenoma, indicating its effectiveness in identifying potential precursors to cancer.

Over an average follow-up of 8 years, only 0.4% of participants developed invasive colorectal cancer after screening, suggesting that while flexible sigmoidoscopy is a useful screening tool, there are limitations, particularly in detecting cancers located proximal to the splenic flexure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after 10 years of a community-based flexible sigmoidoscopy screening program for colorectal carcinoma. Viiala, CH., Olynyk, JK.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Risk of colorectal cancer after a negative colonoscopy in low-to-moderate risk individuals: impact of a 10-year colonoscopy. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Five-year colon surveillance after screening colonoscopy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Colonoscopy surveillance after polypectomy may be extended beyond five years. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Baseline Colonoscopy Findings Associated With 10-Year Outcomes in a Screening Cohort Undergoing Colonoscopy Surveillance. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Surveillance after colorectal polyp removal. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of colonoscopy adverse events in the prospective Cooperative Studies Program no. 380 colorectal cancer screening and surveillance cohort. [2023]

7. Australia pubmed.ncbi.nlm.nih.gov

Outcomes after 10 years of a community-based flexible sigmoidoscopy screening program for colorectal carcinoma. [2021]