ow dose gemcitabine vs standard dose gemcitabine in advanced lung cancer
Phase 3
- Conditions
- Health Condition 1: null- Advanced non-small cell lung cancer
- Registration Number
- CTRI/2013/02/003422
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 308
Inclusion Criteria
1.Patients with stage IIIB or IV; histological/ cytological proven NSCLC.
2.Signed informed consent.
3.Chemonaive patients non small cell lung cancer
4.Stage IV disease and III B patients for palliative chemotherapy
5.PS 0 to 2
Exclusion Criteria
1.Patients with SVCO, symptomatic brain metastasis
2.Patients with uncontrolled cardiac or neurological illness
3.Patients with deranged end organ functions â?? ANC <1500/cumm, Platelets <100000/cumm. Creat >1.5xULN, Liver enzymes >5 x ULN, Bilirubin >1.5xULN
4.Patients with any other malignancy treated in the last 5 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method OVERALL SURVIVALTimepoint: 1 year
- Secondary Outcome Measures
Name Time Method SIDE EFFECTS, PROGRESSION FREE SURVIVAL, RESPONSE RATESTimepoint: PROGRESSION FREE SURVIVAL AT 1 YEAR