Study on Chemotherapy for Colon Cancer Based on Residual Disease Evaluation

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05174169

Provider View

This clinical trial is exploring the best chemotherapy options for colon cancer patients by checking for circulating tumor DNA (ctDNA) in the blood after surgery. The presence or absence of ctDNA will help determine the need for additional treatment.

Patient Parameters

Program Overview

This study aims to find out if checking for circulating tumor DNA (ctDNA) in the blood after colon cancer surgery can help decide if patients need further chemotherapy. ctDNA is a marker that can indicate if there are any remaining cancer cells in the body. Patients without detectable ctDNA may not need extra chemotherapy, while those with ctDNA might need a specific treatment plan. The study will help determine the best chemotherapy options for these patients.

Description

Currently, there are no specific tests to decide if colon cancer patients need extra chemotherapy after surgery. This study is looking at circulating tumor DNA (ctDNA) in the blood, which can help identify if there are any leftover cancer cells. This method might be better than traditional ways of predicting cancer recurrence. Patients without ctDNA are at a lower risk of cancer coming back and might not need more chemotherapy. For those with ctDNA, the best chemotherapy plan is still unknown. The study will use ctDNA status to help make decisions about additional chemotherapy for patients whose colon cancer has been surgically removed.

Eligibility Criteria

Inclusion Criteria

  • Must be in good general health with a performance status of 0 or 1.
  • Must have confirmed Stage IIB, IIC, or Stage III colon cancer with complete tumor removal.
  • No signs of cancer spread on scans within 45 days before joining the study.
  • Tumor must be located at least 12 cm from the anal verge or above the peritoneal reflection.
  • Must have had a complete tumor removal surgery.
  • Must provide a tumor and blood sample for ctDNA testing after surgery.
  • Tumor must be microsatellite stable or have intact mismatch repair proteins.
  • Must be eligible for all potential chemotherapy drugs used in the trial.
  • Must join the study within 60 days after surgery.
  • Must have adequate blood, liver, and kidney function.
  • HIV-positive patients must have an undetectable viral load.
  • Women of childbearing potential must have a negative pregnancy test.
  • Must agree to regular blood monitoring if taking certain blood thinners.
  • Must have developed a positive ctDNA test during monitoring for re-randomization.
  • Must continue to have a performance status of 0 or 1.
  • Must have adequate blood, liver, and kidney function before re-randomization.

Exclusion Criteria

  • Have a type of colon cancer other than adenocarcinoma.
  • Have evidence of cancer spread.
  • Have had a tumor-related bowel perforation.
  • Have a history of invasive colon cancer.
  • Have had a bone marrow or organ transplant.
  • Have had prior chemotherapy, targeted therapy, or radiation for colorectal cancer.
  • Have had another invasive cancer within 5 years, except for certain non-threatening cancers.
  • Have multiple primary colon or rectal cancers.
  • Have significant heart disease or neuropathy.
  • Have had a blood transfusion within two weeks before ctDNA testing.
  • Have an uncontrolled seizure disorder or infection.
  • Have a known deficiency in certain enzymes or genetic conditions.
  • Be pregnant or breastfeeding.
  • Have other illnesses that make participation inappropriate.
  • Be pregnant or breastfeeding at the time of re-randomization.
  • No longer be eligible for certain chemotherapy treatments.

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