Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNRG Oncology

About this trial

This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

Eligibility criteria

Qualifiers

Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;

Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.

BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.

Platelet count must be greater than or equal to 100,000/mm3; and

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Signatera test
  • mFOLFOX6 3-6 month
  • CAPOX 3 month
  • mFOLFIRINOX
  • mFOLFOX6 6 month
  • CAPOX 6 month

Treatment groups

1,912 Participants
are divided into 4 treatment groups

Sponsors and collaborators

NRG Oncology

Lead sponsor

Natera, Inc.

Collaborator

National Cancer Institute (NCI)

Collaborator