CTRI/2013/02/003422
Not yet recruiting
Phase 3
Phase III Study Evaluating Efficacy and Safety of low dose Gemcitabine compared to standard dose Gemcitabine with platinum in advanced non-small cell lung cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Advanced non-small cell lung cancer
- Sponsor
- Tata Memorial Hospital
- Enrollment
- 308
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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