EUCTR2007-002625-77-IT
Active, not recruiting
Not Applicable
Randomized phase II trial of first line chemoterapy Docetaxel given in combination with Cisplatin for 6 cycles or Docetaxel given in combination with Cisplatin for 3 cycles followed by Docetaxel alone for 3 cycles in patients with advanced non-small-cell lung cancer. - ND
FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO0 sitesJuly 5, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with advanced non-small-cell lung cancer
- Sponsor
- FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Histologically or cytologically confirmed diagnosis of NSCLC;
- •2\)Histologic subtypes may include large cell, squamous cell, or adenocarcinoma or a generic cytological diagnosis of NSCLC;
- •3\)Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supracavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System;
- •4\)Males or females aged between 18 and 70 years;
- •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
- •1\)Prior systemic chemotherapy or immunotherapy. Prior neoadjuvant or adjuvant chemotherapy is allowed if ended at least 12 months before enrollment;
- •2\)Prior radiotherapy for NSCLC to measurable lesions. prior radiotherapy (to \<\_25% of the bone marrow) is allowed in non target lesions. at least 4 weeks must be elapsed since the completion of the radiation therapy and the patient must have all side effects recovered;
- •3\)cyto\-histological diagnosis of small cell lung cancer;
- •4\)patients with symptomatic brain matastases or with leptomeningeal disease;
Outcomes
Primary Outcomes
Not specified
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