Colorectal Neoplasms, Effects of Chemotherapy, Surgery, Metastasis, Local Neoplasm Recurrence
Conditions
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.
Interventions
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactJian Xiao, MD
Outcome results
None listed