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A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

Protocol No
ALLIANCE-A031102
Principal Investigator
Deepak Kilari
Phase
III
Summary
The purpose of this study is to compare the good and bad effects of using standarddoses of chemotherapy to using high-doses of chemotherapy. Both of these types of chemotherapy have been shown to shrink cancer when given as the second chemotherapy treatment, but it is not known whether one type is better than the other. This study will allow researchers to learn whether the high-dose chemotherapy is better, the same, or worse than the standard-dose chemotherapy. In order for one arm to be better than the other, researchers should see at least a 10% increase in the cure rate and/or at least a 3 month increase in the median survival time for patients who are not cured.
Description
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL