Clinical Trial: Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized Phase II-Trial to Determine the Impact of Darbepoetin Alfa on the Frequency of RBC Transfusions in Patients With Metastatic "Poor Prognosis" Germ Cell Tumor Treated With High-Dose
Brief Summary: The aim is to determine the frequency of RBC transfusion in patients with metastatic "poor prognosis" germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without Darbepoetin alfa
Detailed Summary:
Sponsor: University Hospital Tuebingen
Current Primary Outcome: frequency of transfusions (reduction from 90% to 65%)
Original Primary Outcome:
Current Secondary Outcome:
- proportion of patients with no transfusions
- developing of hemoglobin levels
- objective remission rate
- progression-free- and overall-survival (pfs, os)
- quality of life
Original Secondary Outcome:
Information By: University Hospital Tuebingen
Dates:
Date Received: September 13, 2005
Date Started: July 2003
Date Completion:
Last Updated: February 13, 2009
Last Verified: February 2009
