RecruitingNot ApplicableNCT05943210

The Radiation Oncology-Biology Integration Network (ROBIN) Molecular Characterization Trial (MCT) of Standard Short Course Radiotherapy for Rectal Cancer

The Radiation Oncology-Biology Integration Network (ROBIN) Molecular Characterization Trial (MCT) of Standard Short Course Radiotherapy for Rectal Cancer.


Sponsor

Weill Medical College of Cornell University

Enrollment

25 participants

Start Date

May 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This trial (molecular characterization trial) focuses on rectal cancer, a common cancer that is treated with radiotherapy (RT) as standard of care and represents a setting in which to study the effects of RT on the immune system.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting tumor samples and blood from patients with rectal cancer who are receiving a short course of radiation therapy before surgery. Researchers want to understand the biology of how tumors respond to radiation at a molecular level, which could help improve future treatments. **You may be eligible if...** - You are 18 or older and have been diagnosed with rectal cancer (adenocarcinoma) confirmed by biopsy - Your cancer has not spread to distant parts of the body - You have not had prior pelvic radiation, chemotherapy, or surgery for rectal cancer - You are in good physical condition (ECOG performance status 0–1) - Your blood counts and organ function meet the study's requirements **You may NOT be eligible if...** - Your rectal cancer has come back after previous treatment - Your cancer cannot be surgically removed - You have previously had a stem cell or organ transplant - You are currently taking immune-suppressing medications above a certain dose - You are receiving other cancer treatments or experimental therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONShort Course Radiation Therapy (scRT)

Eligible patients will receive short course radiation therapy (scRT) of 25Gy over 5 days (fractions) for their localized rectal cancer. Research bloods stool and tissue will be collected at three time points: Baseline, end of radiation therapy and at surgery.

PROCEDURETotal Mesenteric Excision (TME)

Subjects are expected to undergo total mesenteric Excision(TME) even if subjects have achieved complete response by imaging.TME is a specific surgical technique used in the treatment of rectal cancer in which the bowel with the tumor is entirely removed along with surrounding fat and lymph nodes.


Locations(5)

The University of Chicago

Chicago, Illinois, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States

Weill Cornell Medical College

New York, New York, United States

New York Presbyterian Hospital - Queens

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05943210


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