Multicenter, phase II study of chemotherapy with dose-dense modified TCF in locally advanced or metastatic gastric cancer. - ND

Conditions: Patients with locally advanced or metastatic gastric cancer.
MedDRA version: 9.1Level: LLTClassification code 10061967Term: Gastric cancer stage IV

Registration Number: EUCTR2007-004693-34-IT

Lead Sponsor: GRUPPO ONCOLOGICO ITALIANO DI RICERCA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Response rate;Secondary Objective: Time to progression Overall survival Safety profile;Primary end point(s): Overall response rate (Complete + partial response).

Secondary Outcome Measures