Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to compare median overall survival of the test arm (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent gastric cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Clinical Cancer Research Organization
• Collaborator: Korean Cancer Study Group
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma

• Subjects must be able to take orally

• Measurable lesion and/or non-measurable lesion defined by RECIST

• ECOG performance status ≦ 1

• Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3

• Creatine ≦ upper normal limit (UNL)

• Total bilirubin ≦ 1.5 X UNL

• AST, ALT and ALP ≦ 2.5 x UNL

• No prior chemotherapy

• Life expectancy estimated than 3 months

• Written informed consent

Exclusion Criteria:

• Active double cancer

• Gastrointestinal bleeding

• Excessive amounts of ascites require drainage

• Known brain metastases

• Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0

• Pulmonary fibrosis, Intestinal pneumonitis

• History of hypersensitivity to fluoropyrimidines, docetaxel or medications formulated with polysorbate 80

• Any previous chemotherapy or radiotherapy for AGC

• Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant

• Treatment with any investigational product during the last 4 weeks prior to study entry

• Definite contraindications for the use of corticosteroids

• Any subject judged by the investigator to be unfit for any reason to participate in the study