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

NCT01038661 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2014-02-28

No results posted yet for this study

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.

Conditions

  • Lung Neoplasms

Interventions

DRUG

Docetaxel

Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV

DRUG

Cisplatin

Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV

OTHER

Best supportive care (BSC)

Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01038661 on ClinicalTrials.gov