A Phase II Randomized Trial of Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin in Stage IIIB/IV Non-Small Cell Lung Cancer
Most patients suffered from nausea, vomiting and prolonged anorexia after cisplatin
treatment. Epirubicin is an anthracycline that was used widely in the treatment of cancer.
Our previous study of an epirubicin and paclitaxel combination in non-small cell lung cancer
patients showed a response rate of 52.6% and good median survival. However, most patients
suffered from paclitaxel-related neurotoxicity.
Chemotherapy may increase an average of 1 to 2 months of median survival in inoperable
non-small cell lung cancer patients treated with chemotherapy. However, chemotherapy may not
provide a cure for these patients. Reduction of side effects and enhancement of life quality
of the patients are as important as life prolongation for these patients. We designed a
combination chemotherapy using gemcitabine with epirubicin in the treatment of inoperable
non-small cell lung cancer. The treatment will be compared to gemcitabine and cisplatin
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of this study is to explore efficacy of gemcitabine and epirubicin in the treatment of NSCLC patients who need palliative chemotherapy.
Chin-Hsin Yang, M.D., Ph.D.
Department of Oncology, National Taiwan University Hospital
Taiwan: Department of Health