NCT02445209

Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare efficacy and safety of palliative chemotherapy EOX and mDCF regimens in the first-line treatment of patients with advanced HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma

Detailed description

The main purposes: to determine the overall survival (OS) of patients who have locally advanced inoperable or metastatic HER2-negative gastric and gastroesophageal adenocarcinoma treated with first-line EOX (epirubicin + oxaliplatin + capecitabine) or mDCF (docetaxel + cisplatin + leucovorin + 5fluorouracil) palliative chemotherapy regimens The secondary purposes: to determine safety (as assessed by adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0) and the progression-free survival (PFS)

Conditions

• HER2 Negative Gastric Cancer

Interventions

Type	Name	Description
OTHER	EOX	combined chemotherapy regimen: epirubicin + oxaliplatin + capecitabine
OTHER	mDCF	combined chemotherapy regimen: docetaxel + leucovorin + 5fluorouracil + cisplatin

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2015-05-15
• Last updated: 2015-05-15