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
- Conditions
- Patients with advanced non-small-cell lung cancerMedDRA version: 9.1Level: LLTClassification code 10026532Term: Malignant neoplasm of thorax
- Registration Number
- EUCTR2007-002625-77-IT
- Lead Sponsor
- FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the antitumor activity and safety of docetaxel given for six courses in combination with cisplatin or the same schedule followed by 3 cycles of docetaxel alone.;Secondary Objective: To determine the time to progression, the time to treatment failure and the overall survival in the each treatment arm. To evaluate the quantitative and qualitative aspects of safety in each treatment arm.;Primary end point(s): To assess the antitumor activity and safety of docetaxel given for six courses in combination with cisplatin or the same schedule followed by 3 cycles of docetaxel alone.
- Secondary Outcome Measures
Name Time Method