Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin<br>Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1) | Drug: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease-free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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5-fluorouracil, Irinotecan, Oxaliplatin, Colorectal cancer, neoadjuvant, chemotherapy