Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT02688023

CH-GI-052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin

Experimental group

Description:

Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)

Treatment:

Drug: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1