At a glance
ClinicalIndex Comparison Record- ✓Histologic or cytologic confirmation of single primary non-small cell lung cancer
- ✓No prior chemotherapy or radiation therapy
- ✓No prior malignancy
- ✕Pregnancy or breastfeeding
- ✕Serious concomitant systemic disorder
- ✕Unintentional weight loss greater than 10%
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Study of Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation Therapy in Stage III Unresectable NSCLC
In Brief
A Phase 2 clinical trial evaluating gemcitabine, docetaxel, and 3 other interventions for Non-small Cell Lung Cancer. Completed, enrolled 64 participants across 15 sites in 4 countries.
Detailed Summary
To assess the 2 year survival of patients with Stage III unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.
Study Details
Timeline
Interventions
After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles.
Following cisplatin-etoposide induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In this treatment arm, docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
As part of induction chemotherapy, cisplatin is given 50 mg/m2, IV, day 1, 8, 29 and 36 (spans 2 cycles)
As part of induction chemotherapy, etoposide is given 50 mg/m2, IV, days 1-5 and 29-33 (spans 2 cycles)
In conjunction with induction chemotherapy, radiation therapy is administered at a dose of 200 centi Gray (cGy) per day, Monday through Friday for 6 weeks