Status:
TERMINATED
Mono Versus Polichemotherapy in Non Small Cell Lung Cancer (NSCLC) Elderly Patients
Lead Sponsor:
Armando Santoro, MD
Conditions:
NSCLC
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
Between 10% and 25% of newly diagnosed stage IIIB/stage IV patients currently receive single agent chemotherapy regimens. A significant proportion of these patients will be elderly (70 years of age) a...
Eligibility Criteria
Inclusion
- NSCLC, locally advanced (stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
- Female or male patients aged 70 years and over
- Measurable disease according to RECIST criteria, with at least one measurable lesion
- No prior chemotherapy, biological or immunological therapy
- Adeguate hepatic, renal and bone marrow function
- ECOG Performance Status ≤ 2
- Life expectancy of at least 12 weeks
Exclusion
- Newly diagnosed CNS metastases that have not been treated with surgery or radiation
- Less than 4 weeks since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
- Any other experimental or anti-cancer therapy within 30 days before study drug administration
- Concurrent treatment with any other experimental or anti-cancer therapy
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00754364
Start Date
October 1 2008
End Date
December 1 2015
Last Update
September 10 2022
Active Locations (1)
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1
Istituto Clinco Humanitas
Rozzano, Milan, Italy, 20089