Recruiting

Radiotherapy

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05943210

Conditions

Rectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Short Course Radiation Therapy (scRT)

Total Mesenteric Excision (TME)

Study Details

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

Study ID

NCT05943210

Start date

May 22, 2023

Status verified date

Jun, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Short Course Radiation Therapy (scRT)

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)

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.

Primary outcome measure

  • Number of tissue biopsies obtained from treated patients [ Time Frame: Baseline ]
  • Number of tissue biopsies obtained from treated patients [ Time Frame: Week 1 ]
  • Number of tissue biopsies obtained from treated patients [ Time Frame: Week 6 ]
  • Number of research specimens obtained before RT. [ Time Frame: Baseline ]
  • Number of research specimens obtained after RT. [ Time Frame: Week 1 ]
  • Number of research specimens obtained at the time of surgery. [ Time Frame: Week 6 ]

Central Contacts and Locations

Central contacts

Fabiana Gregucci, M.D.

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

Locations

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Fauzia Arif

farif@uchicagomedicine.org

Principal Investigator:

Sean Pitroda, M.D.

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

ManiDeepika Katta

732-427-6212mk1570@cinj.rutgers.edu

Principal Investigator:

Salma Jabbour, M.D.

New York Presbyterian Brooklyn Methodist Hospital

Recruiting

Brooklyn, New York, United States, 10065

Contacts

Izael Nino

izn4001@med.cornell.edu

Mary Palmer

map9505@med.cornell.edu

Principal Investigator:

Hani Ashamalla, M.D.

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Contacts

Maahi Patel

646-962-3118map4044@med.cornell.edu

Fabiana Gregucci, M.D.

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

Principal Investigator:

Encouse Golden, M.D., Ph.D.

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-06-15.