Understanding how rectal cancer responds to standard treatment before surgery
DISCRN in Rectal Cancer: DISseCting Response to Neoadjuvant Therapy in Rectal Cancer
NA · Memorial Sloan Kettering Cancer Center · NCT06637462
This study is testing how well standard treatments for rectal cancer work before surgery to see if they can help predict how the cancer will change.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 6 sites (Middletown, New Jersey and 5 other locations) |
| Trial ID | NCT06637462 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of invasive adenocarcinoma of the rectum who are eligible for standard treatment regimens.
Not a fit: Patients with prior or concurrent malignancies that could affect treatment outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies for rectal cancer by providing predictive insights into treatment responses.
How similar studies have performed: Other studies have shown promise in understanding treatment responses in rectal cancer, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Middletown, New Jersey and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectal Cancer, Adenocarcinoma of the Rectum, rectal cancer, adenocarcinoma of the rectum, Memorial Sloan Kettering Cancer Center, 24-238