Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
ConditionColon Cancer Stage III
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age20-75
SponsorChungnam National University Hospital
About this trial
A multicenter, open labeled randomized, phase II trial comparing mFOLFIRINOX and mFOLFOX6 as adjuvant treatment for high risk stage III (pT4N1/2 or pTanyN2) colon cancer
Eligibility criteria
Qualifiers
Age of 20-70 years with an ECOG ≤ 2
Age of 71-75 years with an ECOG = 0
Pathologically confirmed high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2)
Curative radical resection (successful R0 resection) within 60 days before randomization
Disqualifiers
Distant metastasis
Middle or lower rectal cancer of need for radiotherapy
Postoperative complication of 3 or more grades of Clavien-Dindo classification
Underlying disease or postoperative condition which is contraindication for chemotherapy
Trial design
Treatments tested in this trial
- mFOLFIRINOX
- mFOLFOX 6
Treatment groups
308 Participants
are divided into 2 treatment groupsSponsors and collaborators
Chungnam National University Hospital
Lead sponsor
Boryung Pharmaceutical Co., Ltd
Collaborator
Source ClinicalTrials.gov