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NRG-GI008 - Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

This study is being done to answer the following question: Can we determine what kind of chemotherapy to recommend to patients based on the presence or absence of circulating tumor DNA (ctDNA) after surgery for colon cancer? We are also doing this study because we want to find out if this approach is better or worse than the usual approach for your colon cancer. The usual approach is defined as care most people get for colon cancer that has been treated with surgery.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

There are often multiple options presented to patients after completing surgery for colon cancer. This study is designed to evaluate what specific kinds of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA). If you are assigned to the group that is to be tested for ctDNA every 3 months, you will have regular check-ups at 3 and 6 months after you join the study and then every 6 months after you join the study without further treatment for your colon cancer. If you develop a positive ctDNA test during this testing, you will be asked to join the ctDNA positive group and to agree to receive chemotherapy for 6 months with the usual chemotherapy drug combinations, FOLFOX or CAPOX, or with another chemotherapy drug combination of 5-fluorouracil (5-FU), leucovorin, oxaliplatin, and irinotecan called mFOLFIRINOX. During screening, patients will sign consent, have a physical exam, vitals performed, labs drawn, an imaging scan, and central ctDNA testing. While on study treatment, at visits, patients will have physical exams, labs drawn, imaging scans, and adverse event assessments.

In-person visits:
up to 24
Total length of participation:
up to 60 months (3-6 months of treatment and follow-up up to five years)

Looking for Specific Volunteers

Able to participate:

  • Pathology from resected tumor tissue must confirm Stage IIIA or Stage IIIB colon adenocarcinoma (T1-3, N1/N1c) with R0 resection.
  • Patient's imaging scan cannot have any signs of metastatic disease (cancer that has spread to other areas).
  • Patients must have had a curative resection of tumor (en bloc complete gross resection).
  • Patient's resected tumor tissue and blood must have central testing for ctDNA
  • The treating physician must feel that the patient is a candidate for all potential treatments used in this trial

Not eligible if:

  • Patient has a colon cancer histology other than adenocarcinoma (including neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).
  • Patient has a tumor-related bowel perforation.
  • Patient has a prior history of colon cancer
  • Patient has received any prior treatment for their colon cancer
  • Patient had any other types of cancer in the last five years (with some exceptions).

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Hanna Sanoff
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Colorectal)

IRB Number

22-3002

ClinicalTrials.gov

NCT05174169

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