Phase 2 Study Comparing Maintenance Oral Etoposide to Observation After High-Dose Chemotherapy and Stem Cell Transplant in Relapsed Germ Cell Tumors

What this Trial Is About

Researchers are evaluating maintenance oral etoposide compared to observation after high-dose chemotherapy HDCT and peripheral-blood stem-cell transplant PBSCT in patients with relapsed germ cell tumor GCT. This randomized phase II trial aims to understand if maintenance treatment can improve progression-free survival in this population. The study focuses on patients who have completed HDCT and PBSCT within the past 16 weeks and have evidence of relapsed non-seminomatous GCT. Participants will be randomly assigned to one of two groups maintenance oral etoposide or observation without additional treatment. Those in the etoposide group will take 50 mg of oral etoposide daily for 21 days in each 28-day cycle, repeated for three cycles. Patients assigned to observation will receive no further treatment and move directly to follow-up monitoring. During the study, participants will undergo regular assessments for disease progression and survival for up to 12 months, with additional monitoring of treatment side effects and tolerability for up to two years. Researchers will evaluate tumor markers, organ function, and overall health status. The main outcome measured is progression-free survival at 12 months, with overall survival and safety also assessed. Participants will be followed closely to track any changes in their condition and response to treatment or observation.

Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT