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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with rectal cancer who plan to have standard treatment before surgery. It uses blood, tissue, and scan tests to learn how people respond to chemotherapy and radiation. Researchers want to see if these tests can help predict whether cancer gets better, gets worse, or stays the same after treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older when you sign the consent form.
  • A tissue test shows invasive rectal adenocarcinoma, a cancer that starts in gland cells and grows into nearby tissue.
  • Your cancer has no known mismatch repair deficiency (a problem fixing damaged DNA) or HER2 amplification (extra copies of the HER2 gene).
  • You can receive and plan to start radiation with capecitabine (preferred) or 5-FU chemotherapy, followed by a chemotherapy combination called CAPEOX, FOLFOX, or FOLIRINOX.
  • If you are a woman who can become pregnant, you must have a negative pregnancy test and use effective birth control from screening through treatment.

Who can't join

  • You have a past or current cancer that could affect the study's checks of treatment safety or how well treatment works.
  • You have had radiation from outside the body aimed at the pelvis, or radioactive seeds placed in the prostate.
  • You are pregnant or breastfeeding.
  • You are a man or woman not using effective birth control.
  • You cannot safely have an MRI scan.
  • You take blood thinners that prevent safe collection of tumor samples from inside the rectum.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (6)

NJ

NY