A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer

NCT ID: NCT06637462

Last Updated: 2025-11-26

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-09

Study Completion Date

2027-10-09

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Cancer Adenocarcinoma of the Rectum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

Endoscopy

Intervention Type DIAGNOSTIC_TEST

Standard of care endoscopy

Interventions

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Endoscopy

Standard of care endoscopy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paul Romesser, MD

Role: CONTACT

646-888-2118

Andrea Cercek, MD

Role: CONTACT

646-888-4189

Facility Contacts

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Paul Romesser, MD

Role: primary

646-888-2118

Paul Romesser, MD

Role: primary

646-888-2118

Paul Romesser, MD

Role: primary

646-888-2118

Paul Romesser, MD

Role: primary

646-888-2118

Paul Romesser, MD

Role: primary

646-888-2118

Paul Romesser, MD

Role: primary

646-888-2118

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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24-238

Identifier Type: -

Identifier Source: org_study_id

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