Clinical trial NCT05179889: Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Colon Cancer Stage III
Keywords: High risk stage III (pT4N1/2 or pTanyN2) colon cancer
Lead sponsor: Chungnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Boryung Pharmaceutical Co., Ltd
First posted: 2022-01-06
Enrollment: 308
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Eligibility criteria: Inclusion Criteria:

1. Age of 20-70 years with an ECOG ≤ 2
2. Age of 71-75 years with an ECOG = 0
3. Pathologically confirmed high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2)
4. Curative radical resection (successful R0 resection) within 60 days before randomization
5. 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)
6. Able to understand and willing to sign and date written voluntary informed consent form
7. Life expectancy ≥ 5 years

Exclusion Criteria:

1. Distant metastasis
2. Middle or lower rectal cancer of need for radiotherapy
3. Postoperative complication of 3 or more grades of Clavien-Dindo classification
4. Underlying disease or postoperative condition which is contraindication for chemotherapy
5. Known hypersensitivity reaction to any study treatment component
6. Familial adenomatosis polyposis or hereditary non-polyposis colorectal cancer
7. Inflammatory bowel disease
8. Previous other malignancy which cannot be curatively treated
9. Pregnancy or breast feeding
10. Any other situation would exclude the patient from study based on the investigator's opinion

Primary outcomes:
measure: Disease free survival (DFS)
timeFrame: 3 years after the operation
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years after the operation
measure: Incidence of treatment-related adverse events
timeFrame: 3 years after the operation
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
affiliation: Chungnam National University Hospital
name: Kyung Ha Lee
role: PRINCIPAL_INVESTIGATOR
References: