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

NCT02076594 Phase 3 TERMINATED

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).

Details

Lead sponsor	Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Phase	Phase 3
Status	TERMINATED
Enrolment	171
Start date	2013-01
Completion	2018-12-31

Conditions

• Locally Advanced Unresectable Gastric Cancer
• Metastatic Gastric Cancer

Interventions

• Docetaxel
• Epirubicin
• Oxaliplatin
• Capecitabine

Primary outcomes

• Progression Free Survival (PFS) — Measured as the time from randomization to the date of local or regional progression, distant metastasis, second primary malignancy or death, assessed up to 18 months of follow up
  To determine the progression free survival (PFS) of patients with locally advanced unresectable or metastatic gastric cancer treated with Docetaxel plus Oxaliplatin plus Capecitabine (Arm A) or with Epirubicin plus Oxaliplatin plus Capecitabine (Arm B)

Countries

Italy