Clinical Trial: Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open-labeled, Randomized, Multicenter Phase III Study of Adjuvant Chemotherapy Comparing Bevacizumab Plus Cisplatin With Cisplatin Regimen in Malignant Pleural Effusion of

Brief Summary: To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).

Detailed Summary:
Sponsor: Chinese PLA General Hospital

Current Primary Outcome: Number of Participants With "Complete Response" and "Partial Response" [ Time Frame: from randomization, This treatment was given every two weeks,responses were made by biweekly ]

Response assessed by type-B ultrasonic tests; Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when >50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR


Original Primary Outcome: Overall Response Rate (ORR, percentage of patients who achieve CR and PR) [ Time Frame: baseline to measured progressive disease biweekly ]

Current Secondary Outcome:

  • Median Progression Free Survival (PFS) [ Time Frame: baseline to biweekly,until disease progression ]
  • Overall Survival (OS) [ Time Frame: randomization to four weeks,until death ]
  • Adverse Reactions [ Time Frame: Up to 1 month after the last treatment ]
  • Qualify of Life (QoL) [ Time Frame: baseline to biweekly,until death ]


Original Secondary Outcome: Same as current

Information By: Chinese PLA General Hospital

Dates:
Date Received: July 25, 2012
Date Started: August 2009
Date Completion:
Last Updated: March 13, 2015
Last Verified: March 2015