Actively Recruiting
The Radiation Oncology-Biology Integration Network (ROBIN) Molecular Characterization Trial (MCT) of Standard Short Course Radiotherapy for Rectal Cancer
Led by Weill Medical College of Cornell University · Updated on 2025-07-28
25
Participants Needed
5
Research Sites
262 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Radiation Oncology-Biology Integration Network (ROBIN) Molecular Characterization Trial (MCT) of Standard Short Course Radiotherapy for Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Age 18 years or older
- ECOG performance status 0-1
- Clinical tumor stage cT2-T3N0 or cT1-3N1 or cT4 or cN2
- Rectal cancer suitable for total mesorectal excision
- No distant metastases
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- Total neoadjuvant therapy (short course radiotherapy followed by consolidative chemotherapy) allowed
- No infections requiring systemic antibiotic treatment
- Hemoglobin greater than 8.0 gm/dL
- Platelet count greater than 150,000/mm3
- Total bilirubin less than or equal to 1.5 times upper limit of normal
- AST less than or equal to upper limit of normal
- ALT less than or equal to 3 times upper limit of normal
- Ability to read, understand, and sign informed consent (with translator if needed)
- Negative serum pregnancy test within 4 weeks before starting treatment for females of reproductive potential
- Women of childbearing potential must agree to use effective contraception from screening through study completion
You will not qualify if you...
- Recurrent rectal cancer
- Primary unresectable rectal cancer not removable with negative margins
- Prior pelvic radiotherapy
- Prior allogenic stem cell or solid organ transplantation
- Use of systemic immunosuppressive medication above 10 mg/day prednisone equivalent within 2 weeks before treatment
- Other medical or psychiatric conditions making participation inappropriate
- Receiving other anticancer or experimental therapies during the study
- Pregnant or breastfeeding women
- Women of childbearing potential unwilling or unable to use effective birth control during and for 4 weeks after the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
3
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 10065
Actively Recruiting
4
Weill Cornell Medical College
New York, New York, United States, 10065
Actively Recruiting
5
New York Presbyterian Hospital - Queens
New York, New York, United States, 11355
Not Yet Recruiting
Research Team
F
Fabiana Gregucci, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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