NCT04804007

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

Randomized Phase 2 Trial of Maintenance Oral Etoposide or Observation Following High-dose Chemotherapy for Relapsed Metastatic Germ-Cell Tumor

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Nabil Adra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label randomized phase II trial of maintenance oral etoposide vs. observation in patinets with relapsed GCT treated with high-dose chemotherapy (HDCT) and peripheral-blood stem-cell transplant (PBSCT).

Detailed description

This is a randomized phase 2 trial of maintenance etoposide versus observation following HDCT+PBSCT for relapsed GCT. Patients who completed HDCT+PBSCT within the past 16 weeks will enroll and randomize in 1:1 fashion to maintenance daily oral etoposide 50mg vs. observation only.

Conditions

• Germ Cell Tumor
• Non-seminomatous Germ Cell Tumor
• Ovarian Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	Etoposide	etoposide will be provided with prescription for etoposide 50mg orally daily for 21 days out of 28 day cycles. Cycles will be repeated every 4 weeks for a total of 3 cycles.

Timeline

• Start date: 2021-03-03
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2021-03-18
• Last updated: 2025-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study