A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer

Not Applicable

Recruiting

• Conditions: Rectal Cancer; Adenocarcinoma of the Rectum

• Registration Number: NCT06637462
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of the study is to learn more about how the body responds to standard treatment (chemoradiation and chemotherapy). The study will use the results of testing down on participants' blook, tissue, and scans to learn more about how people with rectal cancer respond to chemoradiation and chemotherapy treatment and if it is useful for predicting whether a person's cancer get better, gets worse, or stats the same after treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-09
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2027-10-09
• Study Completion: 2027-10-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 18 years of age or older on day of signing informed consent.

• Have a histologically confirmed diagnosis of invasive adenocarcinoma of the rectum with no known mismatch repair deficiency or Her2 amplification.

• Eligible for and plan to initiate standard-of-care therapy with any of the following regimens:

  • Induction fluoropyrimidine (capecitabine [preferred] or 5-FU) based chemoradiation
  • With plan for consolidative CAPEOX, FOLFOX, or FOLIRINOX

• Woman with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use an effective contraceptive method. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Reliable contraception should be used from the time of screening and must be continued throughout the duration of treatment as per standard of care.

Exclusion Criteria

• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
• Patients with prior external beam radiation therapy to the pelvis or brachytherapy seed implantation of the prostate.
• Patients who are pregnant or breastfeeding.
• Men or women not using effective contraception.
• Patients with a contraindication to MR imaging.
• Patients on blood thinners prohibiting endoluminal tumor biopsies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical response	Up to 3 years	To define endoscopic (clinical) response to neoadjuvant therapy at the following time points using the MSK regression schema

Trial Locations

Locations (6)

Memorial Sloan Kettering Monmouth (Limited protocol activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited protocol activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited protocol activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited protocol activities); 🇺🇸 Rockville Centre, New York, United States