Health Condition 1: null- Advanced Stage IIIB/IV Non Small Cell carcinoma of the Lung (Adenocarcinoma & Large cell carcinoma)
Conditions
Interventions
Intervention1: Pemetrexed,Cisplatin: Pemetrexed 500 Mg/M2 Day 1 &
every 3 weeks upto 6 cycles.
Cisplatin 75 Mg/M2 Day 1 &
every 3 weeks upto 6 cycles
Control Intervention1: NONE: NONE
Sponsors
Bhagwan Mahaveer Cancer Hospital Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: Histologic or cytologic diagnosis of NSCLC with locally advanced of Metastatic Disease (Stage IIIB with pleural effusion or stage IV disease ). Patients < 70 years of age. Are lesions measured in at least one dimension with the longest diameter&#8805;20 mm (conventional techniques)or &#8805;10 mm (spiral CT scans and MRI). Performance status of 0 or 1 the ECOG scale. Body functions are adequate. Estimated life expectancy of at least 12 weeks.
Exclusion criteria
Exclusion criteria: Case of Squamous Cell Carcinoma . Prior systemic chemotherapy, chemotherapy for pleurodesis, immunotherapy, or biological therapy for this disease. Treatment within the last 30 days with any investigational drug. Active infection . Serious concomitant systemic disorders . Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin of other malignancy treated at least 5 years previously with no evidence of recurrence). Any brain metastases reported.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS (Progression Free Survival)Timepoint: From the date of end of treatment to the first date of first Disease Progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Treatment Failure; Disease Progression; Overall Survival,Safety Profile general & special attention to Oral/Skin toxicity & MyelosupressionTimepoint: Time to Treatment Failure from the Day of start of Chemotherapy to end of treatment either due to Toxicity or No response; Disease Progression (From the date of end of treatment to the first date of first Disease Progression); Overall Survival : from the date of start of treatment to Death,Safety Profile general & special attention to Oral/Skin toxicity & Myelosupression will be collected during the study. | — |
Countries
India
Contacts
Public ContactDr.Anil Kumar Garg
Outcome results
None listed