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Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

Primary Purpose

Colon Cancer Stage III

Status

Enrolling by invitation

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

mFOLFIRINOX

mFOLFOX 6

About this trial

This is an interventional treatment trial for Colon Cancer Stage III focused on measuring High risk stage III (pT4N1/2 or pTanyN2) colon cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chungnam National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

mFOLFIRINOX

mFOLFOX 6

Outcomes

Primary Outcome Measures

Disease free survival (DFS)

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

Secondary Outcome Measures

Overall survival (OS)

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

Incidence of treatment-related adverse events

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

Full Information

NCT ID

NCT05179889

First Posted

December 17, 2021

Last Updated

August 28, 2023

Sponsor

Chungnam National University Hospital

Collaborators

Boryung Pharmaceutical Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05179889

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

July 6, 2021 (Actual)

Primary Completion Date

March 15, 2025 (Anticipated)

Study Completion Date

March 15, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chungnam National University Hospital

Collaborators

Boryung Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer Stage III

Keywords

High risk stage III (pT4N1/2 or pTanyN2) colon cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

308 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

mFOLFIRINOX

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

mFOLFOX 6

Intervention Type

Drug

Intervention Name(s)

mFOLFIRINOX

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

mFOLFOX 6

Intervention Description

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 Measure Information:

Title

Disease free survival (DFS)

Description

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 Outcome Measure Information:

Title

Overall survival (OS)

Description

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

Time Frame

3 years after the operation

Title

Incidence of treatment-related adverse events

Description

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

Time Frame

3 years after the operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyung Ha Lee

Organizational Affiliation

Chungnam National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chungnam National University Hospital

City

Daejeon

ZIP/Postal Code

34112

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

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