High-dose Chemotherapy Using TI-CE Regimen as Second-line Treatment for Men with Relapsed Germ Cell Tumors

What this Trial Is About

This research aims to evaluate high-dose chemotherapy as a second-line drug therapy for patients with advanced germ cell tumors who have not responded to prior platinum-containing first-line chemotherapy. The study focuses on patients with germ cell tumors located in gonadal and extragonadal areas, addressing the unmet need for optimal salvage treatment strategies in this group. It is a prospective, single-center, non-randomized phase II trial designed to assess treatment efficacy and safety. Participants will receive two cycles of high-dose TI chemotherapy, which includes paclitaxel and ifosfamide, followed by three cycles of high-dose CE chemotherapy consisting of carboplatin and etoposide. Autologous stem cell transplantation will be performed after CE cycles. Growth factor support and leukapheresis will be used to collect stem cells if certain blood cell levels are achieved. The treatment cycles are carefully timed and supported by medications to aid recovery. Throughout the study, patients will undergo regular assessments including imaging to evaluate tumor response, laboratory tests to monitor blood counts and organ function, and quality of life evaluations. Researchers will measure progression-free survival as the primary outcome over 24 months, with additional monitoring of overall survival, adverse events, and prognostic factors up to several years post-treatment. Rehabilitation possibilities and stem cell mobilization improvements will also be assessed, with long-term follow-up over five years.

High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors