(A031102) A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Pacilitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors
Description: 
Germ cell tumors (GCT) represent the most common malignancy affecting adolescent and young adult men in both Europe and the United States.[1] Early stage disease, which affects the majority of GCT patients, is nearly universally curable with local or short-course systemic therapy such that current efforts are focused on defining the least toxic means to achieve cure rather than improving efficacy. In contrast, up to 30 percent of patients with advanced GCT will not be cured with initial chemotherapy with or without surgery and therefore require salvage treatment.[2] Furthermore, up to 20 percent of advanced GCT patients will ultimately die from disease progression; then death from GCT occurs, it accounts for the greatest average number of years of life lost of any adolescent or adult malignancy.[3] Therefore, improving therapeutic outcomes for patients undergoing salvage chemotherapy for advanced GCT is a major priority of clinical trials in this disease. At present, the two major salvage approaches are high-dose chemotherapy (HDCT) with autologous stem cell transplant (ASCT) or conventional-dose chemotherapy (CDCT) incorporating cisplatin,ifosfamide, and either vinblastine (VeIP) or paclitaxel (TIP). Due to a lack of conclusive randomized trials, it remains unclear whether sequential HDCT or CDCT represents the optimal initial salvage approach. Defining standards and optimizing outcomes of salvage treatment thus represents one of the most pressing issues in the management of GCT at present.
Study Number: 

NCG 275515

Phase: 
3
Principal Investigator: 
ClinicalTrials.Gov ID: 
NCT02375204

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