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

Phase 3

Recruiting

• Conditions: Local Neoplasm Recurrence; Effects of Chemotherapy; Surgery; Metastasis; Colorectal Neoplasms
• Interventions: Drug: Irinotecan; Drug: 5-fluorouracil; Radiation: Local radiotherapy; Procedure: R0 resection

• Registration Number: NCT02087475
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

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 Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-05
• Primary Completion: 2021-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant therapy arm	Local radiotherapy	FOLFIRI \* 6 cycles +/- radiotherapy -\> surgery -\> FOLFIRI \* 6 cycles
Adjuvant therapy arm	R0 resection	Surgery -\> FOLFIRI \* 12 cycles +/- radiotherapy
Neoadjuvant therapy arm	R0 resection	FOLFIRI \* 6 cycles +/- radiotherapy -\> surgery -\> FOLFIRI \* 6 cycles
Adjuvant therapy arm	Local radiotherapy	Surgery -\> FOLFIRI \* 12 cycles +/- radiotherapy
Neoadjuvant therapy arm	Irinotecan	FOLFIRI \* 6 cycles +/- radiotherapy -\> surgery -\> FOLFIRI \* 6 cycles
Neoadjuvant therapy arm	5-fluorouracil	FOLFIRI \* 6 cycles +/- radiotherapy -\> surgery -\> FOLFIRI \* 6 cycles
Adjuvant therapy arm	Irinotecan	Surgery -\> FOLFIRI \* 12 cycles +/- radiotherapy
Adjuvant therapy arm	5-fluorouracil	Surgery -\> FOLFIRI \* 12 cycles +/- radiotherapy

Primary Outcome Measures

Name	Time	Method
Progress Free Survival	3 years

Secondary Outcome Measures

Name	Time	Method
Overall Survival	3 Years
R0 Resection Rate	6 Month
Treatment RelatedToxicity	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	3 Years	EORTC QoL Questionaires

Trial Locations

Locations (1)

The 6th Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China