NCT02087475

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

Randomized Open-label Phase III Study Comparing Perioperative FOLFIRI Versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer Failed to Oxaliplatin-containing Treatment

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms
• Effects of Chemotherapy
• Surgery
• Metastasis
• Local Neoplasm Recurrence

Interventions

Type	Name	Description
DRUG	Irinotecan
DRUG	5-fluorouracil
RADIATION	Local radiotherapy
PROCEDURE	R0 resection

Timeline

• Start date: 2011-01-01
• Primary completion: 2021-12-01
• Completion: 2024-12-01
• First posted: 2014-03-14
• Last updated: 2019-06-05

Locations

1 site across 1 country: China