Patients with locally advanced or metastatic gastric cancer. MedDRA version: 9.1 Level: LLT Classification code 10061967 Term: Gastric cancer stage IV
Conditions
Interventions
Trade Name: TAXOTERE
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Docetaxel
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concen
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 years. Istologically confirmed gastric adenocarcinoma. Unresectable stage III or stage IV disease. Measurable or evaluable disease. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ECOG PS ≥ 2. Previous chemotherapy for advanced disease. Adjuvant treatments are allowed if ended at least 6 months before. Adequate hepatic, renal and hematological functions. History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix. Patients who are:pregnant or lactating;at risk of pregnancy during the study. This must be checked by pregnancy test at study entry. The patient must be receiving a medically accepted contracceptive regimen. Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule. Refusal to give and sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate;Secondary Objective: Time to progression Overall survival Safety profile;Primary end point(s): Overall response rate (Complete + partial response). | — |
Countries
Italy
Outcome results
None listed