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Colon CancerOpen to EnrollmentPhase 3

COLON: ADJUVANT: Treatment based on MRD: NRG-GI008

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

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Study snapshot

Title
NRG Colon NRG-GI008
Malignancy
Colon
Stage
Stage 3
Disease setting
Adjuvant/Post-surgical
Line of therapy
Adjuvant
Investigational agent
FOLFOX vs FOLFIRINOX vs active surveillance
Drug class
chemo
Principal investigator
Noam VanderWalde, MD
Sponsor
NRG
Path
Adenocarcinoma
Randomized
Yes
ClinicalTrials.gov ID
NCT05174169

Eligibility and objectives

Key eligibility criteria details

  • Patients must have histologically/pathologically confirmed colon adenocarcinoma (T1-3, N1/N1c) with R0 resection accordingly to AJCC 8th edition criteria. NOTE: Patients with pathologic stages II or IIIC colon adenocarcinoma with R0 resection who have a commercially obtained Signatera™ ctDNA+ve assay result post-operatively meeting all timelines and eligibility requirements otherwise, are eligible for enrollment and inclusion in Cohort B.
  • No radiographic evidence of overt metastatic disease
  • Distal extent of tumor must be greater than or equal to 12cm from the anal verge
  • Must have had curative resection (en bloc)
  • Resected tumor specimen and blood must have central testing for ctDNA useing the Signatera assay
  • Must be microsatellite stable or have intact mismatch proteins
  • No more than 60 days post surgery to study entry
  • No other invasive malignancy within 5 years
  • No known active cardiac disease

Objective

  • Primary
    • ctDNA positive status
    • DFS
  • Secondary
    • Baseline post-surgery ctNDA positivity rate
    • OS
    • Time to recurrence
    • Compliance with therapy

Treatment details