What side effects are associated with this type of intervention?

The most common treatments for rectal adenocarcinoma include surgery, chemotherapy, and radiation therapy. Surgical treatments, such as abdominoperineal resection (APR), can lead to poor anorectal function, characterized by increased stool frequency, incontinence, perianal irritation, and decreased rectal compliance, which negatively impact quality of life. Chemotherapy and radiation therapy are associated with side effects such as nausea, vomiting, pain, appetite loss, and long-term decreased quality of life, especially when combined with surgery. These treatments aim to manage the disease but come with significant adverse effects that need to be weighed against their benefits.

What prior FDA approvals exist?

FDA-approved treatments for rectal adenocarcinoma include several chemotherapy agents and targeted therapies. Bevacizumab, an anti-VEGF antibody, is approved for use in combination with chemotherapy agents like capecitabine and oxaliplatin. Pembrolizumab, an immune checkpoint inhibitor, is approved for use in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumors. These treatments are often used in conjunction with radiation therapy as part of a neoadjuvant or adjuvant treatment strategy.

What other types of research exist?

Promising alternatives to surveillance colonoscopy for rectal adenocarcinoma patients include Endoscopic Ultrasound (EUS) for its accuracy in detecting local recurrence, MRI for detailed imaging and staging, and fecal testing for non-invasive monitoring. These methods can complement or, in some cases, replace colonoscopy, providing effective surveillance and early detection.

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5-Year vs. 10-Year Colonoscopy for Colorectal Cancer Prevention (FORTE Trial)

N/A

Recruiting

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Complete excision of all observed polyps in qualifying colonoscopy

Participants must be able to read or understand English or Spanish.

Must not have

Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.)

Family history of CRC diagnosed at greater than or equal to 60 years of age in a first degree relative (mother, father, child, sibling) or in two first degree relatives with CRC at any age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Colonoscopy side effects can include discomfort, bloating, cramps during the procedure; rare risks involve bleeding or tearing in the colon wall.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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All polyps found during my colonoscopy were completely removed.

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I can read or understand English or Spanish.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have had a large growth in my colon before.

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I have a family history of significant colorectal cancer risk (FAP or Lynch Syndrome).

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I have an inflammatory bowel condition like Crohn's or ulcerative colitis.

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My last colonoscopy showed I have traditional serrated adenomas.

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I have a small growth in my colon that is 1 cm or smaller.

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I have a genetic mutation linked to a high risk of colorectal cancer.

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I have had colorectal cancer or polyps before, but not found in my last colonoscopy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of colorectal cancer

Other study objectives

Colorectal cancer mortality

Incidence of advanced adenoma

Incidence of stage III-IV colorectal cancer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment1 Intervention

10-Year Surveillance Colonoscopy after Qualifying Colonoscopy

Group II: Arm 1Experimental Treatment1 Intervention

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

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Rectal Adenocarcinoma include surgery, chemotherapy, and radiotherapy. Surgery physically removes the tumor, which is essential for localized disease. Chemotherapy, using drugs like fluorouracil and oxaliplatin, targets rapidly dividing cancer cells to reduce tumor size and prevent metastasis. Radiotherapy employs high-energy radiation to damage the DNA of cancer cells, leading to their death and tumor shrinkage. These treatments are crucial for rectal adenocarcinoma patients as they address both local and systemic disease, improving survival rates and reducing recurrence. Surveillance colonoscopy is important for early detection and monitoring, ensuring timely intervention if cancer recurs.