Adjuvant FOLFOXIRI for High-risk Stage III Colon Cancer

• Sponsor: Chungnam National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05179889
• Collaborator: Boryung Pharmaceutical Co., Ltd (Industry)
• Enrollment: 308
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 80.3
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

A multicenter, open labeled randomized, phase II trial comparing FOLFOXIRI and mFOLFOX6 as adjuvant treatment for high risk stage III (pT4N1/2 or pTanyN2) colon cancer

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Stage III	Drug: FOLFOXIRI; Drug: mFOLFOX 6	Phase 2/Phase 3

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: FOLFOXIRI Arm B: mFOLFOX

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 308 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: FOLFOXIRI Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III (pT4N1/2 or pTanyN2) Colon Cancer: Multicenter, Open Labeled Randomized, Phase II Study
• Actual Study Start Date: Jul 6, 2021
• Anticipated Primary Completion Date: Mar 15, 2025
• Anticipated Study Completion Date: Mar 15, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A FOLFOXIRI	Drug: FOLFOXIRI; Irinotecan 165 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
Active Comparator: Arm B mFOLFOX 6	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

Outcome Measures

Primary Outcome Measures

1. Disease free survival (DFS) [3 years after the operation]

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

Secondary Outcome Measures

1. Overall survival (OS) [3 years after the operation]

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

2. Incidence of treatment-related adverse events [3 years after the operation]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

1. Able to understand and willing to sign and date written voluntary informed consent form

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungnam National University Hospital	Daejeon		Korea, Republic of	34112

Sponsors and Collaborators

• Chungnam National University Hospital
• Boryung Pharmaceutical Co., Ltd

Investigators

• Principal Investigator: Kyung Ha Lee, Chungnam National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyung-ha Lee, Associate professor, Chungnam National University Hospital
• ClinicalTrials.gov Identifier: NCT05179889
• Other Study ID Numbers: 2020-11-062
• First Posted: Jan 6, 2022
• Last Update Posted: Jan 6, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kyung-ha Lee, Associate professor, Chungnam National University Hospital: High risk stage III (pT4N1/2 or pTanyN2) colon cancer
• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

No Results Posted as of Jan 6, 2022