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Study of Standard Treatment for Rectal Cancer

This study is looking at how people with rectal cancer respond to standard treatments like chemoradiation and chemotherapy before surgery. Researchers want to understand if testing your blood, tissue, and scans can help predict if your cancer will improve, worsen, or stay the same after treatment. You might be able to join if you are 18 or older, have been diagnosed with invasive adenocarcinoma of the rectum, and do not have certain genetic markers (mismatch repair deficiency or Her2 amplification). You must also be planning to start standard treatments like fluoropyrimidine (capecitabine or 5-FU). The main goal is to see your clinical response to treatment, which will be checked for up to 3 years. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 60 participants. It is designed to observe how individuals respond to standard treatments for rectal cancer.
What's involved
You would undergo standard-of-care endoscopy and provide blood and tissue samples for testing. The study will also use results from your scans to understand treatment response.
Compensation
Not stated in the trial record.
Follow-up
Your clinical response will be measured for up to 3 years after treatment.

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

NCT06637462

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

Recruiting
NAAges 18+InterventionalDiagnostic
Memorial Sloan Kettering Cancer Center
~60 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Endoscopy

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical response
Measured over Up to 3 years

Conditions

Rectal Cancer
Adenocarcinoma of the Rectum

Explore related trials

Rectal CarcinomaERBB2 GeneMRC1 wt Allele

Where it's being run

6 sites across 2 states
New York4
New Jersey2

Study leadership

  • Paul Romesser, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Paul Romesser, MD
[email protected]
646-888-2118
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Clinical responseUp to 3 years

    To define endoscopic (clinical) response to neoadjuvant therapy at the following time points using the MSK regression schema