Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin
Conditions
Colorectal Neoplasms - Effects of Chemotherapy - Surgery - Metastasis - Local Neoplasm Recurrence
Conditions: official terms
Colorectal Neoplasms - Neoplasm Recurrence, Local - Neoplasms - Recurrence
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Irinotecan Type: Drug
Name: 5-fluorouracil Type: Drug
Name: Local radiotherapy Type: Radiation
Name: R0 resection Type: Procedure
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
The 6th Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Jian Xiao, MD - +8613711114566 - xiao_jian@139.com
Start Date
January 2011
Completion Date
December 2024
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Source
Sixth Affiliated Hospital, Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page