search
Back to results

mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or IIIC Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
mFOLFOXIRI
mFOLFOX6 OR CapeOx
Sponsored by
First Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Cancer, Stage IIIC, Stage IIIB, FOLFOXIRI

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18-75 years
  • ECOG PS 0-1
  • Curative surgery (R0 resection)
  • ypStage III B and ypStage III C
  • No distant metastasis after surgery

Exclusion Criteria:

  • any treatment before surgery including chemotherapy, radiotherapy and targeted agents.
  • Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
  • Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
  • Heart failure grade III/IV (NYHA-classification).
  • Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
  • Subjects with known allergy to the study drugs or to any of its excipients.
  • Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
  • Breast- feeding or pregnant women
  • Lack of effective contraception

Sites / Locations

  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mFOLFOXIRI adjuvant chemotherapy

mFOLFOX6 or CapeOx adjuvant chemotherapy

Arm Description

Patients will receive mFOLFOXIRI once every two weeks for 12 cycles as adjuvant chemotherapy. They can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. Total 24 weeks.

Patients will receive mFOLFOX6 once every two weeks for 12 cycles as adjuvant chemotherapy or CapeOx once every three weeks for 8 cycles as adjuvant chemotherapy. Total 24 weeks.

Outcomes

Primary Outcome Measures

2-year Disease-free survival
Defined as the time from randomization to relapse or death, whichever occurred first

Secondary Outcome Measures

Overall survival
Defined as the time from randomization to death from any cause
The grade of toxicity will be assessed using the NCI common toxicity criteria, version 5.0.
Safety
QLQ-C30 Quality of Life questionnaire
postoperative quality of life
Quality of Life assessed by SF-36
postoperative quality of life

Full Information

First Posted
January 18, 2022
Last Updated
January 18, 2022
Sponsor
First Affiliated Hospital of Wenzhou Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05200299
Brief Title
mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or IIIC Colorectal Cancer
Official Title
mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or Stage IIIC Colorectal Cancer: A Randomized Controlled Clinical Research
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will focus on postoperative patients of stage IIIB or stage IIIC colorectal cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these patients were randomly divided into two groups, one group will accept adjuvant chemotherapy of mFOLFOX6 or CapeOX; another group will use mFOLFOXIRI, they can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. The efficacy and safety of adjuvant chemotherapy will be compared between the two groups. Disease-free survival, overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of life will be recorded.
Detailed Description
This trial is a two-arm, open labelled, prospective, randomized phase II studies. The postoperative stage of eligible patients was stage IIIB or stage IIIC. These high risk patients will be randomly assigned, in a 1:1 ratio, to receive either mFOLFOXIRI or mFOLFOX6/CapeOx for 6 months as adjuvant chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer, Stage IIIC, Stage IIIB, FOLFOXIRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mFOLFOXIRI adjuvant chemotherapy
Arm Type
Experimental
Arm Description
Patients will receive mFOLFOXIRI once every two weeks for 12 cycles as adjuvant chemotherapy. They can change the regimen to mFOLFOX6 or CapeOx after accepting not less than two complete chemotherapy regimen, if can not tolerate the adverse reaction of mFOLFOXIRI. Total 24 weeks.
Arm Title
mFOLFOX6 or CapeOx adjuvant chemotherapy
Arm Type
Active Comparator
Arm Description
Patients will receive mFOLFOX6 once every two weeks for 12 cycles as adjuvant chemotherapy or CapeOx once every three weeks for 8 cycles as adjuvant chemotherapy. Total 24 weeks.
Intervention Type
Drug
Intervention Name(s)
mFOLFOXIRI
Other Intervention Name(s)
Oxaliplatin, Irinotecan, Leucovorin, 5-Fluorouracil
Intervention Description
mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150-165 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400-2800mg/m2 as a 46-48 hour continuous infusion on day 1)
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6 OR CapeOx
Other Intervention Name(s)
Oxaliplatin, Leucovorin, 5-Fluorouracil, Capecitabine
Intervention Description
mFOLFOX6(oxaliplatin 85 mg/m2, folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-48 hour continuous infusion on day 1) CapeOx(Oxaliplatin 130 mg/m2 intravenous infusion on day 1,Capecitabine 1000 mg/m2 twice daily PO for 14 days)
Primary Outcome Measure Information:
Title
2-year Disease-free survival
Description
Defined as the time from randomization to relapse or death, whichever occurred first
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Defined as the time from randomization to death from any cause
Time Frame
up to 3 years
Title
The grade of toxicity will be assessed using the NCI common toxicity criteria, version 5.0.
Description
Safety
Time Frame
up to 3 years
Title
QLQ-C30 Quality of Life questionnaire
Description
postoperative quality of life
Time Frame
up to 3 years
Title
Quality of Life assessed by SF-36
Description
postoperative quality of life
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 years ECOG PS 0-1 Curative surgery (R0 resection) ypStage III B and ypStage III C No distant metastasis after surgery Exclusion Criteria: any treatment before surgery including chemotherapy, radiotherapy and targeted agents. Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment. Heart failure grade III/IV (NYHA-classification). Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure. Subjects with known allergy to the study drugs or to any of its excipients. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study. Breast- feeding or pregnant women Lack of effective contraception
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Lechi, M.D.
Phone
008613868803676
Email
yljwenzhou@126.com
Facility Information:
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Lechi, M.D.
Phone
008613868803676
Email
yljwenzhou@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
17470860
Citation
Falcone A, Ricci S, Brunetti I, Pfanner E, Allegrini G, Barbara C, Crino L, Benedetti G, Evangelista W, Fanchini L, Cortesi E, Picone V, Vitello S, Chiara S, Granetto C, Porcile G, Fioretto L, Orlandini C, Andreuccetti M, Masi G; Gruppo Oncologico Nord Ovest. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol. 2007 May 1;25(13):1670-6. doi: 10.1200/JCO.2006.09.0928.
Results Reference
background
PubMed Identifier
33538338
Citation
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Results Reference
background
PubMed Identifier
25580262
Citation
Stintzing S. Management of colorectal cancer. F1000Prime Rep. 2014 Nov 4;6:108. doi: 10.12703/P6-108. eCollection 2014.
Results Reference
background
PubMed Identifier
29473957
Citation
Walker R, Wood T, LeSouder E, Cleghorn M, Maganti M, MacNeill A, Quereshy FA. Comparison of two novel staging systems with the TNM system in predicting stage III colon cancer survival. J Surg Oncol. 2018 Apr;117(5):1049-1057. doi: 10.1002/jso.25009. Epub 2018 Feb 23.
Results Reference
background

Learn more about this trial

mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or IIIC Colorectal Cancer

We'll reach out to this number within 24 hrs