A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer
NCT ID: NCT06637462
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-10-09
2027-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Participants with Rectal Cancer
Participants will be diagnosed with rectal cancer and will be undergoing standard-of-care neoadjuvant therapy.
Endoscopy
Standard of care endoscopy
Interventions
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Endoscopy
Standard of care endoscopy
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Paul Romesser, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited protocol activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Paul Romesser, MD
Role: primary
Paul Romesser, MD
Role: primary
Paul Romesser, MD
Role: primary
Paul Romesser, MD
Role: primary
Paul Romesser, MD
Role: primary
Paul Romesser, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-238
Identifier Type: -
Identifier Source: org_study_id
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