Clinical Trial: Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Randomized Open-label Phase III Study Comparing Perioperative FOLFIRI Versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer Failed to Oxaliplatin-containing Treatment
Brief 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.
Detailed Summary:
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Current Primary Outcome: Progress Free Survival [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Overall Survival [ Time Frame: 3 Years ]
- R0 Resection Rate [ Time Frame: 6 Month ]
- Toxicity [ Time Frame: 3 Year ]Adverse events grade that greater than 3 is considered secondary endpoint, according to the Common Terminology Criteria for Adverse Events Version 3.0.
- Life Quality [ Time Frame: 3 Years ]EORTC QoL Questionaires
Original Secondary Outcome: Same as current
Information By: Sixth Affiliated Hospital, Sun Yat-sen University
Dates:
Date Received: March 7, 2014
Date Started: January 2011
Date Completion: December 2024
Last Updated: March 12, 2014
Last Verified: March 2014
