Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin

Phase 3UnknownNCT02087475

Sixth Affiliated Hospital, Sun Yat-sen University360 enrolled

Overview

Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase III mode.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

360

Conditions

Colorectal Neoplasms Effects of Chemotherapy Surgery Metastasis Local Neoplasm Recurrence

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age:18-80 * ECOG score: 0 or 1 * Histological confirmed of Colorectal Adenocarcinoma * History of exposure to oxaliplatin * With local recurrent or metastatic focus * Tumor resectable confirmed by at less 3 hepatobiliary surgeon * Informed content acquired Exclusion Criteria: * History of Exposure to Irinotecan * Received surgery in recently 4 weeks or did not recover from surgery * Other history of cancer in recent 5 years * Fluorouracil allergy or dihydropyrimidine dehydrogenase defect * Women with potential pregnancy.

Outcomes

Primary Outcomes

Progress Free Survival

Time frame: 3 years

Secondary Outcomes

Overall Survival

Time frame: 3 Years

R0 Resection Rate

Time frame: 6 Month

Treatment RelatedToxicity

Adverse events grade that greater than 3 is considered secondary endpoint, according to the Common Terminology Criteria for Adverse Events Version 3.0.

Time frame: 3 Year

Life Quality

EORTC QoL Questionaires