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

Phase 3

Completed

• Conditions: Lung Neoplasms
• Interventions: Drug: Docetaxel; Other: Best supportive care (BSC); Drug: Cisplatin

• Registration Number: NCT01038661
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-24
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²	Cisplatin	Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Maintenance treatment: docetaxel (60 mg/m2)	Docetaxel	Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles
Maintenance treatment: best supportive care (BSC)	Best supportive care (BSC)	BSC until progressive disease
First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²	Docetaxel	Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²	Cisplatin	Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²	Docetaxel	Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) during the maintenance treatment phase	From 2nd randomization to progression or death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)

Secondary Outcome Measures

Name	Time	Method
Time to disease progression (TTP) during the maintenance treatment phase	From 2nd randomization up to disease progression (every 2 cycles (6 weeks))
Disease control rate (DCR) during the first line treatment phase	Every 2 cycles (6 weeks)
Overall response rate (ORR) during the first line treatment phase	Every 2 cycles (6 weeks)
Overall survival (OS)	From 1st randomization to death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇳 Shanghai, China