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ROBIN Molecular Characterization Trial for Rectal Cancer

This study is looking at how short course radiation therapy (scRT) affects the immune system in people with rectal cancer. You would receive scRT for 5 days, which is a standard treatment. Researchers will collect blood, stool, and tissue samples at the beginning, after radiation, and during surgery to understand how your body responds. The main goal is to see if radiation helps your immune system fight the cancer. This trial is for adults aged 18 to 90 with localized rectal cancer who haven't had prior pelvic radiation, chemotherapy, or surgery for their cancer. The study plans to enroll 25 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 25 participants.
What's involved
You would receive short course radiation therapy for 5 days. Blood, stool, and tissue samples will be collected at three time points: before treatment, after radiation, and during surgery.
Compensation
Not stated in the trial record.
Follow-up
Tissue biopsies are measured at Baseline, Week 1, and Week 6. The full follow-up duration is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05943210

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

Recruiting
NAAges 18–90InterventionalBasic science
Weill Medical College of Cornell University
~25 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Short Course Radiation Therapy (scRT)Total Mesenteric Excision (TME)

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of tissue biopsies obtained from treated patients
Measured over Baseline
+5 more outcomes measured

Conditions

Rectal Cancer

Explore related trials

Rectal Carcinoma

Where it's being run

5 sites across 3 states
New York3
Illinois1
New Jersey1

Study leadership

  • Silvia Formenti, M.D. · STUDY_CHAIR · Weill Medical College of Cornell University
  • Encouse Golden, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Fabiana Gregucci, M.D.
[email protected]
646-962-2199
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Number of tissue biopsies obtained from treated patientsBaseline

    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.

  • Number of tissue biopsies obtained from treated patientsWeek 1

    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.

  • Number of tissue biopsies obtained from treated patientsWeek 6

    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.

  • Number of research specimens obtained before RT.Baseline

    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.

  • Number of research specimens obtained after RT.Week 1

    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.

  • Number of research specimens obtained at the time of surgery.Week 6

    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.