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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05080673
Recruitment Status : Recruiting
First Posted : October 18, 2021
Last Update Posted : April 1, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Colon Adenocarcinoma of the Rectum Procedure: 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Surveillance
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Actual Study Start Date : October 6, 2021
Estimated Primary Completion Date : November 1, 2035
Estimated Study Completion Date : November 1, 2065

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
5-Year and 10-Year Surveillance Colonoscopy after Qualifying Colonoscopy
 Procedure: 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy
The five- and ten-year colonoscopies, in addition to any unscheduled colonoscopies, will be performed according to currently accepted guidelines for the performance of quality colonoscopy. Participants will be given the standardized colonoscopy preparation instructions per institutional standards.
Experimental: Arm 2
10-Year Surveillance Colonoscopy after Qualifying Colonoscopy
 Procedure: 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy
The five- and ten-year colonoscopies, in addition to any unscheduled colonoscopies, will be performed according to currently accepted guidelines for the performance of quality colonoscopy. Participants will be given the standardized colonoscopy preparation instructions per institutional standards.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of colorectal cancer [ Time Frame: 10 years ]
    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.


Other Outcome Measures:
  1. Incidence of advanced adenoma [ Time Frame: 10 years ]
    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.

  2. Colorectal cancer mortality [ Time Frame: 10 years ]
    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.

  3. Incidence of stage III-IV colorectal cancer [ Time Frame: 10 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    • 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.
    • Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization.
    • Complete excision of all observed polyps in qualifying colonoscopy
    • Participants must be able to read or understand English or Spanish.

Exclusion Criteria:

  • • 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 less than or equal to 1 cm in size found on the qualifying colonoscopy.
    • Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin.
    • Colonoscopy performed after the qualifying colonoscopy but prior to randomization.
    • Incomplete qualifying colonoscopy (e.g., cecum not visualized).
    • Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.)
    • 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.
    • Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer [Lynch Syndrome]).
    • Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer [Lynch Syndrome] genetic mutation that increases risk of colorectal cancer.
    • Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis).
    • Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator.
    • Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05080673


Contacts
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Contact: Director, Department of Regulatory Affairs 412-339-5300 langerj@nrgoncology.org
Contact: Norman Wolmark, MD

Locations
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Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Robert Schoen, MD University of Pittsburgh
More Information
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Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT05080673    
Other Study ID Numbers: NRG-CC005
NCI-2020-00733 ( Registry Identifier: CTRP )
First Posted: October 18, 2021    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Adenomatous Polyps
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Adenoma