Spots Global Cancer Trial Database for Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
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Trial Identification
Brief Title: Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
Official Title: Randomized Phase 2 Trial of Maintenance Oral Etoposide or Observation Following High-dose Chemotherapy for Relapsed Metastatic Germ-Cell Tumor
Study ID: NCT04804007
Interventions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Indiana University Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, United States
Contact Details
Name: Nabil Adra, MD
Affiliation: Indiana University
Role: PRINCIPAL_INVESTIGATOR
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