Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Drug: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1

• Registration Number: NCT02688023
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2014-03
• Status Verified: 2016-02
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-17
• Last Update Submitted: 2016-02-17
• Study First Posted: 2016-02-23
• Last Update Posted: 2016-02-23
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin	oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1	Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)

Primary Outcome Measures

Name	Time	Method
3-year disease-free survival	5 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China