Study on Blood Test for Predicting Treatment in Stage IIA Colon Cancer After Surgery

Sponsor: NRG Oncology

Sponsor score: 0

ClinicalTrials ID:NCT04068103

This clinical trial is exploring how a blood test that detects tiny amounts of cancer DNA can help decide if patients with stage IIA colon cancer need further treatment after surgery.

Patient Parameters

Program Overview

This study is investigating whether a blood test that looks for small pieces of cancer DNA, called circulating tumor DNA (ctDNA), can help predict which patients with stage IIA colon cancer might benefit from additional treatment after surgery. These tiny cancer DNA fragments are released into the blood by tumors. If ctDNA is found, it suggests that some cancer may still be present, even if it can't be detected by other tests. This trial aims to see if ctDNA testing can identify patients who would benefit from chemotherapy after surgery and those who would not.

Description

The main goals of this study are to compare how well patients with detected ctDNA respond to chemotherapy after surgery for stage IIA colon cancer and to see if this affects their cancer coming back. The study will also look at how common it is to find ctDNA in these patients after surgery and how it relates to their overall survival and cancer recurrence. Additionally, the study will assess how well patients follow through with chemotherapy or active monitoring after surgery.

Eligibility Criteria

Inclusion Criteria

  • Must have signed a consent form approved by the review board.
  • Must have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have a confirmed diagnosis of stage IIA colon cancer with specific tumor characteristics.
  • Must be suitable for active monitoring without chemotherapy, as decided by the oncologist.
  • The tumor must be located at least 12 cm from the anal verge, excluding certain rectal cancers.
  • Must have had a complete tumor removal surgery within 14 to 60 days before joining the study.
  • Must provide a tumor sample for testing.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test before joining the study.
  • Patients on certain blood thinners must agree to regular monitoring if they receive specific chemotherapy.

Exclusion Criteria

  • Have a type of colon cancer other than adenocarcinoma.
  • Have evidence of cancer spread beyond the colon.
  • Have had a bowel perforation related to the tumor.
  • Have a history of invasive colon cancer.
  • Have had an organ transplant.
  • Have received prior chemotherapy, targeted therapy, immunotherapy, or radiation for colorectal cancer.
  • Have had another invasive cancer within the past 5 years, with some exceptions.
  • Have multiple primary colon or rectal cancers.
  • Have uncontrolled heart disease that would prevent using study drugs.
  • Have severe nerve damage or active seizure disorder.
  • Have an active infection requiring treatment.
  • Have a known deficiency in a specific enzyme (DPD).
  • Be pregnant or breastfeeding.
  • Have other health issues that would make participating in the study unsafe.
  • Have previously used a ctDNA test for managing colon cancer.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham Cancer Center35233BirminghamAlabama
University of South Alabama Mitchell Cancer Institute36688MobileAlabama
Anchorage Associates in Radiation Medicine98508AnchorageAlaska
Anchorage Radiation Therapy Center99504AnchorageAlaska
Alaska Breast Care and Surgery LLC99508AnchorageAlaska
Alaska Oncology and Hematology LLC99508AnchorageAlaska
Alaska Women's Cancer Care99508AnchorageAlaska
Anchorage Oncology Centre99508AnchorageAlaska
Katmai Oncology Group99508AnchorageAlaska
Providence Alaska Medical Center99508AnchorageAlaska

Get This Program In Your Inbox

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