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
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | The 6th Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sixth Affiliated Hospital, Sun Yat-sen University |
China,
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 |
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