Colon Cancer Stage IIIPhase 2/3NCT05179889
Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer
A Phase 2/3 study testing mFOLFIRINOX and mFOLFOX 6 in people with Colon Cancer Stage III, run by Chungnam National University Hospital at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Colon Cancer Stage III
- What is being tested?
- mFOLFIRINOX and mFOLFOX 6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jul 2021to 15 Mar 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chungnam National University Hospital
Daejeon, 34112
Kyung Ha Lee, 01042141415, lllllkh@cnuh.co.kr
About this study
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
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
Read the 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
- Conditions
- Colon Cancer Stage III
- Being tested
- mFOLFIRINOX, mFOLFOX 6
- Keywords
- High risk stage III (pT4N1/2 or pTanyN2) colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | mFOLFIRINOX Receives: Drug: mFOLFIRINOX |
| Arm B | Active comparator | mFOLFOX 6 Receives: Drug: mFOLFOX 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
the time from the date of operation to the date of the first recurrence or the death from any cause
Measured: 3 years after the operation
Secondary outcomes (2)
Overall survival (OS)
the time from the date of operation to the date of the death from any cause
Measured: 3 years after the operation
Incidence of treatment-related adverse events
Toxicity of all grade and more than grade 3 based on CTCAE version 5.0
Measured: 3 years after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start6 Jul 2021
- Primary completion5 Jul 2028 (estimated)
- Study completion15 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon Cancer Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, Kyung-ha Lee, Chungnam National University Hospital
- Investigators
- Kyung Ha Lee, Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179889
- Sponsor's protocol ID
- 2020-11-062
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38553680
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05179889
- Acronym / sponsor ID
- 2020-11-062
- Conditions
- Colon Cancer Stage III
- Keywords
- High risk stage III (pT4N1/2 or pTanyN2) colon cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Collaborators
- Boryung Pharmaceutical Co., Ltd
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 5 Jul 2028 (estimated)
- Study completion
- 15 Mar 2031 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: mFOLFIRINOXmFOLFIRINOX |
| Arm B | Active comparator | Drug: mFOLFOX 6mFOLFOX 6 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mFOLFIRINOXIrinotecan 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 | Drug | Arm A |
| mFOLFOX 6Oxaliplatin 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 | Drug | Arm B |
Primary outcome
Disease free survival (DFS)
Time frame: 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
2 secondary outcomes
Overall survival (OS)
Time frame: 3 years after the operation
Incidence of treatment-related adverse events
Time frame: 3 years after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Derived from this study: PubMed 38553680Lee 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.
Related trials for Colon Cancer Stage III
RecruitingPhase 3
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
Colorectal Cancer Stage II, Colorectal Cancer Stage III
RecruitingPhase 3
Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
Metastatic Colorectal Cancer (CRC)
Not yet recruitingPhase 2
Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer
Colon Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 2/3
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
Stage III Colon Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyung Ha Lee principal investigator
Chungnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing mFOLFIRINOX and mFOLFOX 6 in people with Colon Cancer Stage III, run by Chungnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyung Ha Lee (821042141415, lllllkh@cnuh.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: 3 years after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05179889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.