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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Adenocarcinoma of the Rectum; Rectal Cancer

Treatments: Diagnostic Test: Endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06637462

24-238

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Participants with Rectal Cancer

Experimental group

Description:

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

Treatment:

Diagnostic Test: Endoscopy