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Brief Title: Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy
Official Title: Randomized, Controlled Study Comparing the Efficacy and Safety of Docetaxel (60mg/m2)Maintenance Treatment vs. Best Supportive Care Following First Line Chemotherapy With Different Doses of Docetaxel(75/60mg/m2)in Combination With Cisplatin in Patients With Local Advanced or Metastatic (Stage IIIB/IV)Non-Small Cell Lung Cancer
Study ID: NCT01038661
Brief Summary: The Primary Objective is to evaluate the progression-free survival (PFS). The secondary objectives are: * To compare the disease control rates of different doses of Docetaxel+Cisplatin as first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria; * To evaluate the overall response rate (ORR); * To evaluate the time to disease progression (TTP); * To evaluate the overall survival (OS); * To evaluate the toxicity.
Detailed Description: The study consists in: * A first line treatment phase: participants receive 4 cycles of chemotherapy (each cycle contains 3 weeks) with either docetaxel (75 mg/m2) plus cisplatin (75 mg/m2) or docetaxel (60 mg/m2) plus cisplatin (75 mg/m2) , * A maintenance treatment phase: participants with disease control (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]) after the initial treatment receive up to 6 cycles of chemotherapy with docetaxel (60 mg/m2) or best supportive care (BSC). * A follow-up period from the end of study treatment until participant death or end of study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sanofi-Aventis Administrative Office, Shanghai, , China
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR