ow-doses radiotherapy and concomitant chemotherapy with pemetrexed in progression desease NSCLC: a dose-descalation phase II study - ND
- Conditions
- advanced and/or metastatic NSCLCMedDRA version: 9.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastatic
- Registration Number
- EUCTR2008-003690-40-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Age > 18
histologic or cytologic confirmation of NSCLC
measurable disease
PS = ECOG 0-2
WBC ≥3500 e PLT ≥ 100.000
adequate bone marrow, renal, and hepatic function.
written informed consent before treatment
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
prior chemotherapy with pemetrexed
autoimmune disease interfering with radiotherapy
pregnancy
other concomitant neoplasm
mentally disturbed patients with low compliance to treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method