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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02087475
• Other study ID #: SAH 5010 CRC
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2011
• Est. completion date: December 2024

Study information

• Verified date: June 2019
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Jian Xiao, MD
• Phone: +8613711114566
• Email: xiao_jian[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 2024
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Irinotecan

• 5-fluorouracil

Radiation:
• Local radiotherapy

Procedure:
• R0 resection

Locations

Country	Name	City	State
China	The 6th Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress Free Survival		3 years
Secondary	Overall Survival		3 Years
Secondary	R0 Resection Rate		6 Month
Secondary	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.	3 Year
Secondary	Life Quality	EORTC QoL Questionaires	3 Years