Quality of Life Comparison in Advanced Non-squamous Non Small Cell Lung Cancer
- Sponsor
- Gruppo Oncologico Italia Meridionale
- Study ID
- NCT01303926
- Phase
- PHASE3
- Status
- Unknown
Conditions
- Non-squamous Nonsmall Cell Neoplasm of Lung
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- cisplatin pemetrexed — DRUGCisplatin 75 mg / m2 d1 with Pemetrexed 500 mg / m2 d1 every 3 weeks for 6 cycles followed (in responding or stable patients) by Pemetrexed 500 mg / m2 every 3 weeks, until progression or unacceptable toxicity
- carboplatin paclitaxel bevacizumab — DRUGCarboplatin AUC 6 d1 plus Paclitaxel 200 mg/m2 d1 and Bevacizumab 15 mg/kg every 3 weeks for 6 cycles followed in stable or responding patients by Bevacizumab 15 mg/kg every 3 weeks, until progression or unacceptable toxicity
Study Details
Cisplatin and pemetrexed combination or carboplatin, paclitaxel and bevacizumab are now considered as standard treatment in non-squamous cell lung carcinoma (NSCLC). Both main registrative trials are considered positive because they reached their objectives, but within them, the Quality of Life (QoL) of patients was not detailed neither has represented as primary objective of the studies. It is considered that, together with enhancements that are added to the knowledge of the biology of NSCLC, QoL may influence the therapeutic choice if one of the associations show to be better tolerated by the patient and favours an amelioration of his QoL.
Key Dates
- First listed
- Feb 25, 2011
- Start date
- Jan 31, 2010
- Status verified
- Apr 2012
- Primary completion
- Jun 30, 2012
- Completion
- Jun 30, 2012
Study Design
- Enrollment
- 118 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Cisplatin and Pemetrexed
- Active Comparator: Carboplatin paclitaxel bevacizumab
Primary Outcome Measure
Difference in terms of quality of life (QOL) between treatment arms [ Time Frame: Treatment efficacy will be evaluated at baseline and every 3 cycles during chemo period and every two months during the maintenance phase ]