NCT02076594

Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer

A Randomized Phase III Study Of Low-Docetaxel Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin And Capecitabine (Eox) In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, parallel group, non-blinded phase III trial. Patients with advanced (locoregional or metastatic) gastric cancer not previously treated with chemotherapy for this stage will be randomized in a 1:1 ratio to receive low-TOX (arm A) or EOX (arm B). Randomization will be stratified by performance status (ECOG 0, 1 and 2).

Detailed description

Although the incidence of the adenocarcinoma of the stomach is slowly decreasing, gastric cancer represents the second worldwide cause of cancer death after lung cancer. In patients with advanced disease, chemotherapy improves survival and quality of life. Combinations of two or three drugs including a platin derivative (cisplatin or oxaliplatin), a fluoropyrimidine (5FU or capecitabine) and an anthracycline (usually epirubicin) have demonstrated superiority compared to single or double agent therapy and are the current standard. As of today there are no published studies comparing anthracycline-based to taxane-based three-drug regimens. The objective of the present study is to compare EOX as evaluated in REAL-2 to the low-TOX regimen consisting of docetaxel, oxaliplatin and capecitabine. Low-TOX is expected to be better tolerated than the original DCF regimen. The study will be performed in the HER2 negative patients.

Conditions

• Locally Advanced Unresectable Gastric Cancer
• Metastatic Gastric Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Powder for solution for infusion
DRUG	Epirubicin	Solution for infusion
DRUG	Oxaliplatin	Powder for solution for infusion
DRUG	Capecitabine	Film coated tablets

Timeline

• Start date: 2013-01-01
• Primary completion: 2018-12-01
• Completion: 2018-12-31
• First posted: 2014-03-03
• Last updated: 2019-10-09

Locations

25 sites across 1 country: Italy