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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


Phase 3
18 Years
60 Years
Open (Enrolling)
Both
Malignant Pleural Effusion

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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

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