Study on Identifying and Treating Hidden Cancer Cells in Stage III Colon Cancer

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03803553

Provider View

This clinical trial is comparing different standard treatments for patients with Stage III colon cancer based on blood test results. The study aims to find out if additional treatments can help prevent cancer from coming back.

Patient Parameters

Program Overview

This study is exploring different treatment options for patients with Stage III colon cancer who have had surgery to remove their tumors. Researchers are using a blood test to detect tiny amounts of cancer DNA, called circulating tumor DNA (ctDNA), which might indicate that cancer could return. The study compares active monitoring with additional treatments like FOLFIRI, Nivolumab, Encorafenib/Binimetinib/Cetuximab, and Trastuzumab + Pertuzumab to see if they can reduce the chance of cancer coming back.

Description

After surgery, patients with Stage III colon cancer usually receive chemotherapy to kill any remaining cancer cells. However, if some cancer cells survive, they might be detected in the blood as circulating tumor DNA (ctDNA). This study aims to find out if additional treatments can help prevent cancer from returning in patients who test positive for ctDNA.

The study involves different treatment groups:

  • Active Surveillance: Regular monitoring with scans to check if cancer returns.
  • FOLFIRI Treatment: A combination of chemotherapy drugs (Irinotecan, Leucovorin, and 5-Fluorouracil) to target cancer cells.
  • Nivolumab Treatment: An immunotherapy drug that helps the immune system recognize and attack cancer cells.
  • Encorafenib/Binimetinib/Cetuximab Treatment: A combination targeting specific genetic mutations in cancer cells to slow their growth.
  • Trastuzumab + Pertuzumab Treatment: Targeted therapy for cancers with specific genetic markers.

The study will compare the effectiveness of these treatments in reducing cancer recurrence and improving patient health. Researchers will also monitor changes in ctDNA levels to see if they correlate with treatment outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must have Stage III colon cancer that has been surgically removed.
  • Cancer must be located in the colon, not the rectum.
  • Must have completed standard chemotherapy after surgery.
  • Must be 18 years or older.
  • Must be in good overall health with a life expectancy of more than 3 months.
  • Must have normal blood and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
  • Must have a positive ctDNA test after chemotherapy to be eligible for certain treatment groups.
  • Must have documentation of specific genetic markers if applicable.

Exclusion Criteria

  • Cannot be participating in another investigational study.
  • Cannot have confirmed metastatic disease.
  • Cannot have received more than 6 months of standard chemotherapy.
  • Cannot have certain genetic mutations for specific treatment groups.
  • Cannot have uncontrolled health conditions that would interfere with the study.
  • Cannot be pregnant or breastfeeding.
  • Cannot have other active cancers requiring treatment.
  • Cannot have received a live vaccine recently.
  • Cannot have certain heart conditions or severe allergies to study drugs.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.