Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

Colon Cancer Stage III Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05179889
• Other study ID #: 2020-11-062
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: July 6, 2021
• Est. completion date: March 15, 2028

Study information

• Verified date: August 2023
• Source: Chungnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 308
• Est. completion date: March 15, 2028
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer Stage III
• Colonic Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon

Sponsors (2)

Lead Sponsor	Collaborator
Chungnam National University Hospital	Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival (DFS)	the time from the date of operation to the date of the first recurrence or the death from any cause	3 years after the operation
Secondary	Overall survival (OS)	the time from the date of operation to the date of the death from any cause	3 years after the operation
Secondary	Incidence of treatment-related adverse events	Toxicity of all grade and more than grade 3 based on CTCAE version 5.0	3 years after the operation