NCT01567618

Dose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer

A Phase II Trial Evaluating Biweekly Docetaxel and DeGramont Regimen in First-Line Treatment of Unresectable or Metastatic Gastric Adenocarcinoma (DaeMon)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.

Detailed description

Primary endpoint: Overall Response Rate Secondary endpoint: Time to progression, overall survival, safety data

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel 50mg/m2 iv drip, repeat every two weeks; Efficacy will be evaluated every three cycles.
DRUG	Fluorouracil	Fluorouracil 400mg/m2 iv D1; Fluorouracil 2400mg/m2 civ 46 hours; repeat fortnightly and evaluate every two cycles

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-09-01
• Completion: 2014-04-01
• First posted: 2012-03-30
• Last updated: 2014-11-07

Locations

1 site across 1 country: China