Clinical trial NCT05200299: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Stage IIIC
Stage IIIB
FOLFOXIRI
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 2-year Disease-free survival
timeFrame: up to 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: up to 3 years
measure: The grade of toxicity will be assessed using the NCI common toxicity criteria, version 5.0.
timeFrame: up to 3 years
measure: QLQ-C30 Quality of Life questionnaire
timeFrame: up to 3 years
measure: Quality of Life assessed by SF-36
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
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.
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.
citation: Stintzing S. Management of colorectal cancer. F1000Prime Rep. 2014 Nov 4;6:108. doi: 10.12703/P6-108. eCollection 2014.
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.