Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2/PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-06

Study Completion Date

2028-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

IRinotecan and Oxaliplatin for Colon Cancer in Adjuvant Setting

NCT02967289

Colon Cancer (High-risk Stage III: pT4N1 or pT1 to 4 N2)

COMPLETED PHASE3

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

NCT05174169

Stage III Colon Cancer

RECRUITING PHASE2/PHASE3

MFOLFOXIRI Plus PD-1 Inhibitor Vs MFOLFOX6 As Neoadjuvant Therapy for Locally Advanced Colon Cancer

NCT06890624

Colon Cancer (stage II &amp; III)

NOT_YET_RECRUITING PHASE2

Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer

NCT06197425

Colon or Upper Rectum Adenocarcinoma

NOT_YET_RECRUITING PHASE3

Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12)

NCT05534087

Colon Cancer

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Cancer Stage III

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

mFOLFIRINOX

Group Type EXPERIMENTAL

mFOLFIRINOX

Intervention Type DRUG

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

Arm B

mFOLFOX 6

Group Type ACTIVE_COMPARATOR

mFOLFOX 6

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No