Status:
COMPLETED
Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer
Lead Sponsor:
Japan Clinical Cancer Research Organization
Collaborating Sponsors:
Korean Cancer Study Group
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-79 years
Phase:
PHASE3
Brief 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.
Detailed Description
Seven-hundred and fifty thousand of new gastric cancer cases are diagnosed worldwide per year. Advanced gastric cancer (AGC) is considered nearly incurable with less than 10% of subjects alive 5 years...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT00287768
Start Date
March 1 2006
End Date
October 1 2010
Last Update
June 28 2011
Active Locations (116)
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1
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
2
Aichi Medical University Hospital
Okazaki, Aichi-ken, Japan, 480-1195
3
Akita University Hospital
Akita, Akita, Japan, 010-8543
4
Nakadoori General Hospital
Akita, Akita, Japan, 010-8577