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

NCT05943210 | Recruiting DMC FDA Device

• 2 other identifiers: 22-080251211U54CA274291
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (6)

• Number of tissue biopsies obtained from treated patients

  To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.

  Baseline

• Number of tissue biopsies obtained from treated patients

  To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.

  Week 1

• Number of tissue biopsies obtained from treated patients

  To conduct a multi-centric prospective clinical trial of standard short course RT in the neoadjuvant setting of rectal cancer (MCT), with harmonized tissue acquisition and immune characterization across seven international centers, and assess quality of life during MCT and pathological response at surgery.

  Week 6

• Number of research specimens obtained before RT.

  To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.

  Baseline

• Number of research specimens obtained after RT.

  To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.

  Week 1

• Number of research specimens obtained at the time of surgery.

  To obtain a unique set of biospecimens of optimal quality for cutting-edge imaging and multi-omics analyses at the single cell level that are spatially integrated, obtained longitudinally before and after RT and at the time of surgery.

  Week 6

Secondary Outcomes (13)

• Changes in tumor morphology from pre-treatment and post-treatment MRI will be measured.

  Baseline, Week 1

• Changes in tumor morphology from pre-treatment and post-treatment CT will be measured.

  Baseline, Week 1

• Changes in tumor texture from pre-treatment and post-treatment MRI will be measured.

  Baseline, Week 1

• Changes in tumor texture from pre-treatment and post-treatment CT will be measured.

  Baseline, Week 1

• Changes in enhancement kinetics from pre-treatment and post-treatment MRI will be measured.

  Baseline, Week 1

Study Arms (1)

Single cohort

OTHER

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.

Radiation: Short Course Radiation Therapy (scRT); Procedure: Total Mesenteric Excision (TME)

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.

Single cohort

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.

Single cohort

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of adenocarcinoma of the rectum
• Age ≥ 18 years
• ECOG performance status 0-1
• cT2-T3N0 or cT1-3N1 or cT4 or cN2
• Rectal cancer amenable to total mesorectal excision
• No evidence of 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) is allowed
• No infections requiring systemic antibiotic treatment
• Hgb \>8.0 gm/dL, PLT \> 150,000/mm3, total bilirubin ≤ 1.5x upper limit of normal, AST ≤ upper limit of normal, ALT ≤ 3x upper limit of normal
• Patients must read, agree to, and sign a statement of informed consent prior to participation in this study. Patients who do not read or understand English or eligible but must have the consent form read to them in its entirety by an official translator. Informed consent for non-literate or non-English speaking patients may not be obtained by using a relative or a member of the patient's clinical team as a translator.
• Female participants or reproductive potential, defined as not surgically sterilized and between menarche and 1 year post menopause, must have a negative serum pregnancy test within 4 weeks prior to initiation of study treatment.
• Women with childbearing potential who are negative for pregnancy (urine or blood) and who agree to use effective contraceptive methods. A woman of childbearing potential is defined by one who is biologically capable of becoming pregnant. Reliable contraception should be used from trial screening and must be continued throughout the study.

You may not qualify if:

• Recurrent rectal cancer
• Primary unresectable rectal cancer is defined as a primary rectal tumor which, on the basis of either physical exam or pelvic MRI, is deemed to be adherent or fixed to adjacent pelvic structures (en bloc resection will not be achieved with negative margins).
• Patients who have received prior pelvic radiotherapy
• Patients with prior allogenic stem cell or solid organ transplantation.
• Patients receiving treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor-α agents) administered at \>10 mg/day prednisone or equivalent within 2 weeks prior to initiation of study treatment.
• Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment would make them inappropriate candidates for entry into this study
• Patients receiving other anticancer or experimental therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody, or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.
• Women who are pregnant or breastfeeding. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to four weeks after the study.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 10065, United States

RECRUITING

Weill Cornell Medical College

New York, New York, 10065, United States

RECRUITING

New York Presbyterian Hospital - Queens

New York, New York, 11355, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Silvia Formenti, M.D.

  Weill Medical College of Cornell University

  STUDY CHAIR

• Encouse Golden, M.D., Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabiana Gregucci, M.D.

CONTACT

646-962-2199; fgr4002@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a molecular characterization trial (MCT) of 25 consecutively treated rectal cancers with short-course radiotherapy (scRT; 25Gy/5 fractions). Tissue and imaging will be collected at three time-points: 1. Baseline (day -28 to 0) - pelvic MRI and CT, research biopsy, blood (50ml), stool. 2. After 5 RT fractions (day 5-10) - CT, research biopsy, blood (50ml), stool 3. At time of surgery (wk 6) - MRI and CT, surgical tumor and nodal specimens, blood (50ml), stool.

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 13, 2023
• Study Start: May 22, 2023
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)