Colorectal Cancer
Conditions
Keywords
5-fluorouracil, Irinotecan, Oxaliplatin, Colorectal cancer, neoadjuvant, chemotherapy
Brief summary
Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.
Detailed description
This is a single arm, phase 2 study of neoadjuvant triplet chemotherapy regimen of oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.Fifty patients will be enrolled in this trial. The primary objective of this study is to determine the 3-year disease-free survival of the patients.
Interventions
DRUGoxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1
The regimen consisted of irinotecan 150mg/m2 administered as an intravenous infusion on day 1, oxaliplatin 85 mg/m2 administered intravenously on day 2, leucovorin 200 mg intravenously on day 2, 5-fluorouracil 500 mg administered by intravenous bolus,followed by 2400 mg/m2 by 44 h continuous intravenous infusion starting on day 2. S-1 (40-60mg orally twice per day for 10 days) or capecitabine (1000mg/m2 orally twice per day for 10 days) can be substituted for intravenous 5-fluorouracil.14 days as a cycle, up to 4 cycles.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* histologically verified colorectal cancer * clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only) * age: 18-70 years * ECOG 0-2 * adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease) * no prior cancer and/or chemotherapy * signed informed consent
Exclusion criteria
* patients with a history of prior malignancy * pregnant or lactating patients * known or suspected brain metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate | 2 years |
| Surgical complete resection rate (R0) | 2 years |
| overall survival | 6 years |
| Number of participants with adverse events that are related to treatment | 2 years |
| Number of participants with surgery complications | 2 years |
Countries
China
Contacts
Primary ContactJing Huang, M.D.
Outcome results
None listed