Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06637462

DISCRN in Rectal Cancer: DISseCting Response to Neoadjuvant Therapy in Rectal Cancer

Led by Memorial Sloan Kettering Cancer Center ยท Updated on 2026-06-02

60

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how people with rectal cancer respond to standard treatments like chemoradiation and chemotherapy before surgery. The purpose is to understand how the body reacts to these treatments and whether testing blood, tissue, and scans can help predict if the cancer improves, worsens, or stays the same after treatment. This study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on participants with invasive adenocarcinoma of the rectum. Participants will receive standard-of-care neoadjuvant therapy, which includes chemoradiation with induction fluoropyrimidine drugs such as capecitabine or 5-FU, followed by plans for consolidative chemotherapy regimens like CAPEOX, FOLFOX, or FOLIRINOX. Standard endoscopy is used as part of the diagnostic testing during treatment. These treatments and procedures are part of the usual care for rectal cancer, monitored closely within this study. During the study, participants will have tests on their blood, tissue, and scans at different times to help researchers observe the cancer's response to treatment. The main outcome measured is clinical response, which will be followed for up to three years. Participants are monitored for safety and treatment effects throughout this period, with all data collected helping to improve understanding of treatment responses in rectal cancer.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older on day of signing informed consent
  • Histologically confirmed diagnosis of invasive adenocarcinoma of the rectum with no known mismatch repair deficiency or Her2 amplification
  • Eligible for and planning to start standard chemoradiation with induction fluoropyrimidine (capecitabine or 5-FU) based therapy
  • Plan for consolidative chemotherapy with CAPEOX, FOLFOX, or FOLIRINOX
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception throughout treatment
Not Eligible

You will not qualify if you...

  • Prior or concurrent malignancy that may interfere with safety or efficacy assessments
  • Prior external beam radiation therapy to the pelvis or prostate brachytherapy seed implantation
  • Pregnant or breastfeeding patients
  • Men or women not using effective contraception
  • Contraindication to MR imaging
  • Use of blood thinners that prevent endoluminal tumor biopsies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 years

Participants undergo standard of care endoscopy and other diagnostic tests before starting neoadjuvant therapy.

Visits scheduled according to standard care for assessment of clinical response

Long-term Monitoring

Duration - Up to 3 years

Participants are monitored for clinical response and outcomes following neoadjuvant therapy and surgery.

Follow-up visits occurring over several years to assess treatment response

Trial Site Locations

Total: 6 locations

1

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

2

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

3

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

4

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, United States, 10604

Actively Recruiting

5

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

6

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States, 11553

Actively Recruiting

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Research Team

P

Paul Romesser, MD

A

Andrea Cercek, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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