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Recruiting NCT05179889

Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

Phase II / Phase III Interventional Colon Cancer Stage III

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mFOLFIRINOX, mFOLFOX 6.
Who it may be relevant to
Registry conditions: Colon Cancer Stage III. Basic parameters: 20 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

mFOLFIRINOX Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III (pT4N1/2 or pTanyN2) Colon Cancer: Multicenter, Open Labeled, Randomized, Phase II Study

Overview

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

Detailed description

After inclusion and exclusion criteria have been fulfilled and the patient consent has been obtained, the patient will be included and randomized to mFOLFIRINOX or mFOLFOX 6 with a 1:1 ratio.

Arm A: mFOLFIRINOX Arm B: mFOLFOX

Interventions

  • Drug mFOLFIRINOX
    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
  • Drug 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 weeks

Primary outcome measures

  • Disease free survival (DFS) [Time frame: 3 years after the operation]
Secondary outcome measures (2)
  • Overall survival (OS) [Time frame: 3 years after the operation]
  • Incidence of treatment-related adverse events [Time frame: 3 years after the operation]

Eligibility criteria

Inclusion criteria

  • 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
  • Adequate organ functions
  • ANC ≥ 2×106 cells/mL
  • Hemoglobin ≥ 9.0 g/dL
  • Platelets ≥ 100×106 cells/mL
  • Alanine aminotransferase/aspartate aminotransferase ≤2.5 × times the upper limit of normal (ULN)
  • Serum total bilirubin ≤ 1.5 ULN
  • Alkaline phosphatase ≤ 2.5 × ULN
  • Serum creatinine ≤1.5 × ULN or creatinine clearance > 50 mL/min (Cockcroft-Gault formula)
  • Able to understand and willing to sign and date written voluntary informed consent form
  • Life expectancy ≥ 5 years

Exclusion criteria

  • 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
  • Known hypersensitivity reaction to any study treatment component
  • Familial adenomatosis polyposis or hereditary non-polyposis colorectal cancer
  • Inflammatory bowel disease
  • Previous other malignancy which cannot be curatively treated
  • Pregnancy or breast feeding
  • Any other situation would exclude the patient from study based on the investigator's opinion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Chungnam National University Hospital — Daejeon

Publications

  • Lee KH, Yang IJ, Ha GW, Lee J, Park YY, Lee SH, Lee JM, Bae JH, Park EJ, Kim H, Kim KY, An S, Kim IY, Kim JY. mFOLFIRINOX versus mFOLFOX 6 as adjuvant treatment for high-risk stage III colon cancer - the FROST trial: study protocol for a multicenter, randomized controlled, phase II trial. BMC Cancer. 2024 Mar 29;24(1):397. doi: 10.1186/s12885-024-11939-x. PMID 38553680

Identifiers

NCT: NCT05179889 · 2020-11-062

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗