NCT06637462 A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer
| NCT ID | NCT06637462 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-09 |
| Primary Completion | 2027-10-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-10-09 with a primary completion date of 2027-10-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Paul Romesser, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT06637462 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06637462 currently recruiting?
Yes, NCT06637462 is actively recruiting participants. Contact the research team at romessep@mskcc.org for enrollment information.
Where is the NCT06637462 trial being conducted?
This trial is being conducted at Middletown, United States, Montvale, United States, Commack, United States, Harrison, United States and 2 additional locations.
Who is sponsoring the NCT06637462 clinical trial?
NCT06637462 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Paul Romesser, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 60 participants.
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