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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • mFOLFIRINOX

    Drug

    Irinotecan 150 mg/m2 IV day 1, oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 48 hours) continuous infusion\] 12 cycles per 2 weeks mFOLFOX 6 \[Oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 400 mg/m2 IV bolus day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion, 12 cycles per 2 week

  • mFOLFOX 6

    Drug

    Oxaliplatin 85 mg/m2 IV day 1, Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1, 5-FU 400 mg/m2 IV bolus day 1, 5-FU 1200 mg/m2/d IV x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion, 12 cycles per 2 weeks

Treatment groups

308 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 1 intervention
Group B: Arm BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease free survival (DFS)

the time from the date of operation to the date of the first recurrence or the death from any cause

Time frame
3 years after the operation

Secondary outcomes

1

Overall survival (OS)

the time from the date of operation to the date of the death from any cause

Time frame
3 years after the operation
2

Incidence of treatment-related adverse events

Toxicity of all grade and more than grade 3 based on CTCAE version 5.0

Time frame
3 years after the operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chungnam National University Hospital

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Collaborator

Source ClinicalTrials.gov
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