Patients with advanced non-small-cell lung cancer MedDRA version: 9.1 Level: LLT Classification code 10026532 Term: Malignant neoplasm of thorax
Conditions
Interventions
Product Name: Docetaxel
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Docetaxel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Product Name
Sponsors
FONDAZIONE ISTITUTO SAN RAFFAELE-G.GIGLIO
Eligibility
Sex/Gender
All
Inclusion 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
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed