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Brief Title: Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin for Non-Small Cell Lung Cancer (NSCLC)
Official Title: A Phase II Randomized Trial of Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin in Stage IIIB/IV Non-Small Cell Lung Cancer
Study ID: NCT00154739
Brief Summary: The purpose of this study is to evaluate the efficacy of gemcitabine/cisplatin versus gemcitabine/epirubicin in Stage IIIB/IV NSCLC in terms of response rate and overall survival.
Detailed Description: 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 combination.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Oncology, National Taiwan University Hospital, Taipei, , Taiwan
Name: Chin-Hsin Yang, M.D., Ph.D.
Affiliation: Department of Oncology, National Taiwan University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Ann-Lii Cheng, M.D., Ph.D.
Affiliation: Department of Oncology, National Taiwan University Hospital
Role: STUDY_CHAIR