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) — RADIATION
    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.
  • Total Mesenteric Excision (TME) — PROCEDURE
    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.

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 cohort
    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.

Primary Outcome Measure

Number of tissue biopsies obtained from treated patients [ Time Frame: Baseline ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
The University of ChicagoChicagoIllinois60637
Sean Pitroda, M.D. (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901
ManiDeepika Katta
732-427-6212
Salma Jabbour, M.D. (PRINCIPAL_INVESTIGATOR)
New York Presbyterian Brooklyn Methodist HospitalBrooklynNew York10065
Hani Ashamalla, M.D. (PRINCIPAL_INVESTIGATOR)
New York Presbyterian Hospital - QueensNew YorkNew York11355
Hina Ali, M.D.
718-670-1541
Krystalle Lyons
718-670-1574
Andrew Brandmaier, M.D. (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical CollegeNew YorkNew York10065
Maahi Patel
646-962-3118
Fabiana Gregucci, M.D.
646-962-2199
Encouse Golden, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

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