Study on Total Neoadjuvant Therapy with mFOLFOX and Short-Course Radiation for Resectable Rectal Cancer

Sponsor: Virginia Commonwealth University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04643366

Provider View

This phase 2 clinical trial is testing a combination of chemotherapy and short-course radiation therapy before surgery in patients with rectal cancer that can be surgically removed.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness of a treatment plan that includes four cycles of chemotherapy, followed by short-course radiation therapy combined with chemotherapy, and then another four cycles of chemotherapy before surgery. For patients who achieve a complete response, there is an option for active monitoring instead of surgery. The main goal is to see if patients remain free of cancer for three years after treatment.

Description

This clinical trial involves a treatment plan for patients with resectable rectal cancer. Participants will receive four cycles of chemotherapy, followed by short-course radiation therapy combined with chemotherapy. After this, they will undergo another four cycles of chemotherapy before surgery. If patients achieve a complete clinical response, they may choose to be closely monitored instead of having surgery. The study will measure the percentage of patients who remain free of cancer for three years after treatment, starting from the date of complete response or surgery, whichever comes first.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with adenocarcinoma of the rectum within the last 90 days, with part of the tumor located below a certain point in the rectum.
  • Cancer must be at a specific stage based on medical tests, including colonoscopy and imaging scans.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Aged 18 years or older.
  • Have adequate blood cell counts and organ function based on specific blood tests.
  • Must be considered a candidate for surgery by a surgical oncologist.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Must agree to use effective birth control during treatment and for three months after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Previous radiation therapy that overlaps with the planned study treatment.
  • Significant heart disease that prevents receiving certain chemotherapy drugs.
  • Serious uncontrolled infections.
  • Lung or breathing conditions that prevent receiving certain chemotherapy drugs.
  • Major surgery within 28 days before joining the study, except for specific procedures.
  • History of inflammatory bowel disease requiring major treatment.
  • Allergic reactions to specific chemotherapy drugs.
  • Known deficiency in a specific enzyme (DPD).
  • Evidence of cancer spread to distant parts of the body.
  • Pregnant or breastfeeding.
  • Any condition that may increase risk or limit adherence to study requirements.

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