EUCTR2005-001260-31-ITActive, not recruitingNot Applicable
PHASE II MULTICENTRIC STUDY OF SEQUENTIAL CHEMOTHERAPY WITH GEMCITABINE FOLLOWED FROM DOCETAXEL IN ELDERLY PATIENTS WITH NOT SMALL CELLS LUNG CANCER NSCLC ADVANCED - POLTO-Elderly04
AZIENDA USL 6 LIVORNO ZONA LIVORNESE0 sites60 target enrollmentStarted: March 13, 2006Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •pulmonary histologic or cytological Diagnosis of NSLC measurable Disease second criteria RECIST Stage IIIB for cytologically positive pleuric deposit or sopraclavearic metastases Stage IV Age 70 years ECOG performance status 0 - 2 Expected life 3 months Adapted medullary functionality leucociti 4,0 x109/L, neutrophil 2,0 x 109/L, 100 plt x 109/L, emoglobina 10 g/dL Adapted renal hepatic functionality and bilirubinemia 1,2 mg/dL, transaminases 2,5 x VN, creatininemia 1,5 mg/dL informed Consent written
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •Diagnosi the brought back criteria inel protocol of other malignant neoplasie in last the 5 years except the carcinoma in situ of the cervix uterina and the basalioma or ca. to spinocellulare cutaneous adequately deals Previous chemotherapy to you for the metastatic disease Radioterapy on the neoplastic lesions cerebral Metastase sintomatic scompensate metabolic Diseases or infections in action cardiac Aritmye or ischemic cardiopathy not controlled impossibility to execute an adequate one follow-up
Investigators
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