Clinical Trial: Surgery Plus Single Agent Chemotherapy Versus Primary Chemotherapy for Gestational Trophoblastic Neoplasms
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Primary Surgery Plus Single Course Methotrexate Versus Primary Methotrexate for Treatment of Gestational Trophoblastic Neoplasms in Low Risk Cases Above 40y: a Randomized Controled Trial
Brief Summary: Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy especially methotrexate and the investigators try to find a role of surgery plus methotrexate instead of multiple doses and cycles of chemotherapy.
Detailed Summary: Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy espechialy methotrexate and the investigators try to find a role of surgery plus mehotrexate instead of multiple doses and cycles of chemotherapy that affect the patient quality of life and complication related to both line of management and time of decrease of B-hcg.
Sponsor: Maher elesawi kamel elesawi
Current Primary Outcome: number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML [ Time Frame: 1-6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- quality of life( questionairre) [ Time Frame: 1-6 months ]pain scale from zero to 11, return to ordinary activities
- complications from management [ Time Frame: 1-6 months ]renal, hepatic impairments, anemia,
- time interval for B-hCG reach less than 5 MU/ML [ Time Frame: 1-6 months ]the time taken for B-hCG to reach below 5 MU/ML
Original Secondary Outcome: Same as current
Information By: Mansoura University
Dates:
Date Received: August 8, 2015
Date Started: September 2015
Date Completion: August 2017
Last Updated: March 21, 2017
Last Verified: November 2015
