NCT05179889

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for phase_2

Timeline
59mo left

Started Jul 2021

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jul 2021Mar 2031

Study Start

First participant enrolled

July 6, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2028

Expected
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2031

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

7 years

First QC Date

December 17, 2021

Last Update Submit

March 17, 2026

Conditions

Colon Cancer Stage III

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Overall survival (OS)

    3 years after the operation

  • Incidence of treatment-related adverse events

    3 years after the operation

Study Arms (2)

Arm A

EXPERIMENTAL

mFOLFIRINOX

Drug: mFOLFIRINOX

Arm B

ACTIVE COMPARATOR

mFOLFOX 6

Drug: mFOLFOX 6

Interventions

mFOLFIRINOXDRUG

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 A
mFOLFOX 6DRUG

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

Arm B

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, 34112, South Korea

RECRUITING

Related Publications (1)

  • Lee KH, Yang IJ, Ha GW, Lee J, Park YY, Lee SH, Lee JM, Bae JH, Park EJ, Kim H, Kim KY, An S, Kim IY, Kim JY. mFOLFIRINOX versus mFOLFOX 6 as adjuvant treatment for high-risk stage III colon cancer - the FROST trial: study protocol for a multicenter, randomized controlled, phase II trial. BMC Cancer. 2024 Mar 29;24(1):397. doi: 10.1186/s12885-024-11939-x.

    PMID: 38553680DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Kyung Ha Lee

    Chungnam National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung Ha Lee

CONTACT

821042141415lllllkh@cnuh.co.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 17, 2021

First Posted

January 6, 2022

Study Start

July 6, 2021

Primary Completion (Estimated)

July 5, 2028

Study Completion (Estimated)

March 15, 2031

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

KR(1)