Understanding how rectal cancer responds to standard treatment before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate the body's response to standard treatments, specifically chemoradiation and chemotherapy, in patients with rectal cancer. By analyzing blood, tissue, and scan results, researchers hope to determine how effective these treatments are in predicting the progression of the cancer. The findings could provide insights into whether a patient's cancer improves, worsens, or remains stable after treatment. The study will involve participants who are eligible for standard-of-care therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Memorial Sloan Kettering Monmouth (Limited protocol activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited protocol activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited protocol activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting
• Memorial Sloan Kettering Nassau (Limited protocol activities)
  Rockville Centre, New York, United States Recruiting

Study contacts

• Principal investigator: Paul Romesser, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Paul Romesser, MD
• Email: romessep@mskcc.org
• Phone: 646-888-2118

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Aerobic exercise and guided imagery for bowel problems after rectal cancer surgery

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• Active surveillance vs chemoradiotherapy after local removal of intermediate-risk T1 rectal cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.