drugset / Trial / NCT00193921
Chemoradiotherapy in Patients With Localised Lung Cancer
Phase 2
Completed
82 enrolled
Trans Tasman Radiation Oncology Group
Cancer Council Queensland · collabVictorian Cancer Council · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The study compares 2 different methods of combined chemotherapy and radiotherapy for the treatment of localised lung cancer in patients not suitable for surgery. Hypothesis(es) to be tested: 1. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine + high dose palliative radiotherapy in terms of efficacy in a multi-institutional setting 2. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine + high dose palliative radiotherapy in terms of feasibility in a multi-institutional setting 3. Vinorelbine + cisplatin + high-dose palliative radiotherapy has a favourable toxicity profile relative to gemcitabine + high-dose palliative radiotherapy
Timeline
- Start
- 2003-02
- Primary completion
- 2009-12
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 20 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 200 mg | Intravenous |
| Subject | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |