drugset / Trial / NCT01038661
Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2009-11
- Primary completion
- 2012-08
- Completion
- 2012-08
Outcome
Met primary endpoint
paper DCM significantly prolonged PFS compared to BSC (HR =0.57, median PFS =5.8 vs. 3.0 months, P=0.002). PMID 33708965 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |