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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Irinotecan
* Drug: 5-fluorouracil
* Radiation: Local radiotherapy
* Procedure: R0 resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant therapy arm<br>FOLFIRI * 6 cycles +/- radiotherapy -> surgery -> FOLFIRI * 6 cycles | Drug: Irinotecan<br> <br> Drug: 5-fluorouracil<br> <br> Radiation: Local radiotherapy<br> <br> Procedure: R0 resection<br> <br> |
| Active Comparator: Adjuvant therapy arm<br>Surgery -> FOLFIRI * 12 cycles +/- radiotherapy | Drug: Irinotecan<br> <br> Drug: 5-fluorouracil<br> <br> Radiation: Local radiotherapy<br> <br> Procedure: R0 resection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress Free Survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 3 Years | 
| R0 Resection Rate |  | 6 Month | 
| 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 | 
| Life Quality | EORTC QoL Questionaires | 3 Years |