A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer
DISCRN in Rectal Cancer: DISseCting Response to Neoadjuvant Therapy in Rectal Cancer
1 other identifier
interventional
30
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2024
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2024
CompletedStudy Start
First participant enrolled
October 9, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 9, 2027
March 18, 2026
March 1, 2026
3 years
October 9, 2024
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical response
To define endoscopic (clinical) response to neoadjuvant therapy at the following time points using the MSK regression schema
Up to 3 years
Study Arms (1)
Participants with Rectal Cancer
EXPERIMENTALParticipants will be diagnosed with rectal cancer and will be undergoing standard-of-care neoadjuvant therapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited protocol activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Romesser, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2024
First Posted
October 15, 2024
Study Start
October 9, 2024
Primary Completion (Estimated)
October 9, 2027
Study Completion (Estimated)
October 9, 2027
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.