CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 1,912 target
Drug / intervention
mFOLFOX6 3-6 month +5 moredrug
Likely dose
mFOLFOX6 3-6 month 85 mg/m2from record
Key inclusion· 19
  • ✓ECOG performance status 0 or 1
  • ✓Histologically/pathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection
  • ✓No radiographic evidence of overt metastatic disease within 45 days prior to study entry
  • ✓Tumor distal extent ≥12 cm from anal verge on colonoscopy or above peritoneal reflection
Key exclusion· 19
  • ✕Colon cancer histology other than adenocarcinoma
  • ✕Pathologic, clinical, or radiologic overt evidence of metastatic disease
  • ✕Tumor-related bowel perforation
  • ✕History of prior invasive colon malignancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05174169
NCT05174169Phase 2RecruitingHigh Momentum
Long Recruiting
CompareCT.gov

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

NRG Oncology·interventional·Posted Dec 30, 2021·Updated Jun 3, 2026

In Brief

A Phase 2 clinical trial evaluating Signatera test, mFOLFOX6 3-6 month, and 4 other interventions for Stage III Colon Cancer. Currently recruiting, targeting 1,912 participants across 1,061 sites in 3 countries.

Signals

Enrolling ahead of pace

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage III Colon Cancer
CountriesCanada, Puerto Rico, United States
CollaboratorsNatera, Inc., National Cancer Institute (NCI)

Timeline

Phase 2Recruiting
202220232024202520262027202820292030
First PostedDec 30, 2021
Enrollment StartJul 8, 2022
Primary CompletionMar 10, 2029
Study CompletionMar 10, 2030
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 4.5 years agoPrimary completion in 2.7 years

Arms & Interventions

Cohort A - Arm 1 (ctDNA-ve)active_comparator

Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles OR Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles

Device: Signatera testDrug: mFOLFOX6 3-6 monthDrug: CAPOX 3 month
Cohort A - Arm 2 (ctDNA-ve)experimental

Serial ctDNA monitoring no treatment

Device: Signatera test
Cohort B - Arm 3 (ctDNA+ve)active_comparator

Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles OR Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles

Device: Signatera testDrug: mFOLFOX6 6 monthDrug: CAPOX 6 month
Cohort B - Arm 4 (ctDNA+ve)experimental

Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles

Device: Signatera testDrug: mFOLFIRINOX

Interventions

Signatera testdevice

Central ctDNA testing for all patients

mFOLFOX6 3-6 monthdrug

Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles

CAPOX 3 monthdrug

Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles

mFOLFIRINOXdrug

Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles

mFOLFOX6 6 monthdrug

Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles

CAPOX 6 monthdrug

Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles