Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, Stage IIIC, Stage IIIB, FOLFOXIRI
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.
Interventions
DRUGmFOLFOX6 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)
DRUGmFOLFOXIRI
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)
Sponsors
First Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Disease-free survival | up to 2 years | Defined as the time from randomization to relapse or death, whichever occurred first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | up to 3 years | 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. | up to 3 years | Safety |
| QLQ-C30 Quality of Life questionnaire | up to 3 years | postoperative quality of life |
| Quality of Life assessed by SF-36 | up to 3 years | postoperative quality of life |
Countries
China
Contacts
Primary ContactYe Lechi, M.D.
Outcome results
None listed