Sequential first line chemotherapy ECF (epirubicin + cisplatin + 5-fluoruracil) followed by DCF (docetaxel + cisplatin + 5-fluoruracil) in advanced/metastatic gastric cancer HER-2 negative: a phase II study - ECF-DCF

• Conditions: patients with advanced/metastatic gastric cancer not operable HER-2 negative; MedDRA version: 13.1Level: HLTClassification code 10017812Term: Gastric neoplasms malignantSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 13.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 13.1Level: HLGTClassification code 10017991Term: Gastrointestinal neoplasms malignant and unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2010-019756-42-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SENESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-26
• Last Update Posted: 7 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Patients with advanced or metastatic gastric cancer, not operable, at first diagnosis or relapsed after surgery, histologically confirmed, HER-2 negative - Age more than 18 years - Negative pregnancy test within 7 days of starting study treatment in pre-menopausal women - Written informed consent - ECOG performance status 0-3 - No prior chemotherapy or radiation therapy (allowed only if neoadjuvant or adjuvant therapy but without the use of ECF and DCF schedules) - Adequate hematological function: white blood cells >3500/mmc, neutrophils >1500/mmc, platelets >100000/mmc, hemoglobin >10 mg/dl - Adequate liver function: serum bilirubin = 1,5 x ULN; transaminases = 2,5 x ULN (in case liver metastases < 5 x ULN) - Adequate renal function: creatinine clearance > 90 ml/min - Adequate cardiac function - Not other relevant comorbidities - Life expectancy more than three months
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

- Other neoplastic diseases (excepted for cutaneous basalioma) - Pregnant or lactating women - Fertile men or women not using adequate contraception - Organ transplantation - Serious infection disease - Clinically significant cardiovascular disease - Immunodepression (for viral infection or genetic diseases) - Known hypersensitivity to any of the drugs in the study - Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -rate of patients free from disease progression after 6 months from the treatment start;Secondary Objective: -response rate (RR)<br>-time to progression (TTP)<br>-overall survival (OS)<br>-treatment toxicity<br>-quality of life (QoL);Primary end point(s): -rate of patients free from disease progression after 6 months from the treatment start