Trial Information
Open-labled, Randomized, Multicenter Phase III Study of Adjuvant Chemotherapy Comparing Bevacizumab Plus Cisplatin With Cisplatin Regimen in Malignant Pleural Effusion of Advanced Stage Non-Small-Cell Lung Cancer Patients
Inclusion Criteria:
- Patients with advanced recurrent or progressive NSCLC proven cytohistologically
- Karnofsky performance status (KPS) ≥60
- Life expectancy ≥ 2 months
- No history of severe diseases of major organs including liver, heart, and kidney
- No previous intrapleural therapy
- Written informed consent
Exclusion Criteria:
- Active thoracic cavity or systemic bleeding
- Active pleural or systemic infection.
- Known sensitivity to Bevacizumab or Cisplatin
- Refusal to participate in the study.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Response Rate (ORR, percentage of patients who achieve CR and PR)
Outcome Time Frame:
baseline to measured progressive disease biweekly
Safety Issue:
No
Principal Investigator
Nan Du
Investigator Role:
Principal Investigator
Investigator Affiliation:
PLA 304 hospital
Authority:
China: Food and Drug Administration
Study ID:
PLA304DN-001
NCT ID:
NCT01661790
Start Date:
August 2012
Completion Date:
October 2013
Related Keywords:
- Malignant Pleural Effusion
- Bevacizumab;
- non-small cell lung cancer;
- malignant pleural effusion;
- intrapleural administration
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Pleural Effusion
- Pleural Effusion, Malignant