The Radiation Oncology-Biology Integration Network (ROBIN) Molecular Characterization Trial (MCT) of Standard Short Course Radiotherapy for Rectal Cancer
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Weill Medical College of Cornell University
- Study ID
- NCT05943210
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- Short Course Radiation Therapy (scRT) — RADIATIONEligible 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.
- Total Mesenteric Excision (TME) — PROCEDURESubjects 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.
Study Details
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.
Key Dates
- Start date
- May 22, 2023
- Status verified
- Jul 2025
- Primary completion
- May 31, 2028
- Completion
- May 31, 2028
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Other: Single cohortEligible 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.
Primary Outcome Measure
Number of tissue biopsies obtained from treated patients [ Time Frame: Baseline ]
Central Contacts
- Fabiana Gregucci, M.D.646-962-2199
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | Fauzia Arif Sean Pitroda, M.D. (PRINCIPAL_INVESTIGATOR) |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | Salma Jabbour, M.D. (PRINCIPAL_INVESTIGATOR) |
| New York Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | 10065 | Izael Nino Mary Palmer Hani Ashamalla, M.D. (PRINCIPAL_INVESTIGATOR) |
| New York Presbyterian Hospital - Queens | New York | New York | 11355 | Andrew Brandmaier, M.D. (PRINCIPAL_INVESTIGATOR) |
| Weill Cornell Medical College | New York | New York | 10065 | Encouse Golden, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR) |
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