A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1
- Conditions
- Colorectal Cancer
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 3-year disease-free survival
- Last Updated
- 10 years ago
Overview
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.
Investigators
Jing Huang
MD PhD
Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •histologically verified colorectal cancer
- •clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only)
- •age: 18-70 years
- •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
Arms & Interventions
single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin
Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)
Intervention: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1
Outcomes
Primary Outcomes
3-year disease-free survival
Time Frame: 5 years
Secondary Outcomes
- Number of participants with adverse events that are related to treatment(2 years)
- objective response rate(2 years)
- overall survival(6 years)
- Number of participants with surgery complications(2 years)
- Surgical complete resection rate (R0)(2 years)