A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopy.
- Who it may be relevant to
- Registry conditions: Rectal Cancer, Adenocarcinoma of the Rectum. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DISCRN in Rectal Cancer: DISseCting Response to Neoadjuvant Therapy in Rectal Cancer
Overview
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.
Interventions
- Diagnostic test Endoscopy
Standard of care endoscopy
Primary outcome measures
- Clinical response [Time frame: Up to 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 6 centers
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown
- Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack
- Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre
Identifiers
NCT: NCT06637462 · 24-238