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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Treatments: Fluorouracil; Irinotecan; Oxaliplatin

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.