Recruiting

Standard Treatment

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06637462

Conditions

Rectal Cancer

Adenocarcinoma of the Rectum

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopy

Study Details

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.

Conditions

Rectal Cancer

Adenocarcinoma of the Rectum

Study ID

NCT06637462

Start date

Oct 9, 2024

Status verified date

May, 2026

Completion date

Oct 9, 2027

Anticipated

Primary completion date

Oct 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Participants with Rectal Cancer

Participants will be diagnosed with rectal cancer and will be undergoing standard-of-care neoadjuvant therapy.

Interventions

Endoscopy

Standard of care endoscopy

Primary outcome measure

  • Clinical response [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Paul Romesser, MD

646-888-2118romessep@mskcc.org

Andrea Cercek, MD

646-888-4189cerceka@mskcc.org

Locations

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Paul Romesser, MD

646-888-2118

Memorial Sloan Kettering Bergen (Limited protocol activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Paul Romesser, MD

646-888-2118

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Paul Romesser, MD

646-888-2118

Memorial Sloan Kettering Westchester (Limited protocol activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Paul Romesser, MD

646-888-2118

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Paul Romesser, MD

646-888-2118

Memorial Sloan Kettering Nassau (Limited protocol activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Paul Romesser, MD

646-888-2118

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • rectal cancer
  • adenocarcinoma of the rectum
  • Memorial Sloan Kettering Cancer Center
  • 24-238

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-02.