NCT01570582

A Phase IIclinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

A Phase II Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel or Carboplatin and Gemcitabine in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Korean Gynecologic Oncology Group · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

purpose Primary endpoint * To evaluate the 24 month disease free survival Second endpoints * To evaluate the 24 month overall survival To analyze the toxicity and the quality of life

Detailed description

Approximately 48 month from the date of IRB approval Patients enrolled in this study targets approximately 314 people. Completion of patient enrollment is expected to take approximately 24 month, approximately 24 month follow-up period is expected to be needed

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	carboplatin and paclitaxel	Subjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week.

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-04-04
• Last updated: 2012-04-04

Locations

1 site across 1 country: South Korea