A Phase 2 interventional study of mFOLFOXIRI and mFOLFOX6 OR CapeOx in Colorectal Cancer, sponsored by First Affiliated Hospital of Wenzhou Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-20.
Sponsored by First Affiliated Hospital of Wenzhou Medical University · Phase 2, Interventional, and Treatment
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 100 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →First Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 82 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
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.
Drug: mFOLFOXIRI · Drug: mFOLFOX6 OR CapeOx
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.
Drug: mFOLFOX6 OR CapeOx
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)
Also known as: Oxaliplatin, Irinotecan, Leucovorin, 5-Fluorouracil
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)
Also known as: Oxaliplatin, Leucovorin, 5-Fluorouracil, Capecitabine
2-year Disease-free survival
Defined as the time from randomization to relapse or death, whichever occurred first
Time frame: up to 2 years
Overall survival
Defined as the time from randomization to death from any cause
Time frame: up to 3 years
The grade of toxicity will be assessed using the NCI common toxicity criteria, version 5.0.
Safety
Time frame: up to 3 years
QLQ-C30 Quality of Life questionnaire
postoperative quality of life
Time frame: up to 3 years
Quality of Life assessed by SF-36
postoperative quality of life
Time frame: up to 3 years
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First Affiliated Hospital of Wenzhou Medical University