Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy — TFINE  

Lung Neoplasms Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms

• NCT number: NCT01038661
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: November 2009
• Completion date: August 2012