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

Colorectal Cancer Clinical Trial

Official title:

mFOLFOXIRI Compared to mFOLFOX6 or CapeOx as Adjuvant Chemotherapy for Stage IIIB or Stage IIIC Colorectal Cancer: A Randomized Controlled Clinical Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200299
• Other study ID #: T-idea
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2021
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: Ye Lechi, M.D.
• Phone: 008613868803676
• Email: yljwenzhou[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• mFOLFOXIRI
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)
• mFOLFOX6 OR CapeOx
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)

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Falcone A, Ricci S, Brunetti I, Pfanner E, Allegrini G, Barbara C, Crinò 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. — View Citation

Stintzing S. Management of colorectal cancer. F1000Prime Rep. 2014 Nov 4;6:108. doi: 10.12703/P6-108. eCollection 2014. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year Disease-free survival	Defined as the time from randomization to relapse or death, whichever occurred first	up to 2 years
Secondary	Overall survival	Defined as the time from randomization to death from any cause	up to 3 years
Secondary	The grade of toxicity will be assessed using the NCI common toxicity criteria, version 5.0.	Safety	up to 3 years
Secondary	QLQ-C30 Quality of Life questionnaire	postoperative quality of life	up to 3 years
Secondary	Quality of Life assessed by SF-36	postoperative quality of life	up to 3 years