Randomized Phase 2 Trial of Maintenance Oral Etoposide or Observation Following High-dose Chemotherapy for Relapsed Metastatic Germ-Cell Tumor
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.
Arms & interventions
- DrugEtoposide
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.
Outcome measures
Primary
12-month Progression Free Survival
Investigator determination of tumor progression (clinical, radiographic, tumor markers including AFP and hCG)
Time frame: time from the date of randomization to the date of disease relapse or death (i.e. up to 1 year)
Secondary
12-month Overall Survival
Time frame: Time of registration to death from any cause (i.e. up to 1 year)
Assess toxicity and tolerability of maintenance etoposide
Time frame: through study completion (i.e. up to 2 years)
Eligibility criteria
Study locations (1)
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
References
- Taza F, Abonour R, Zaid MA, Althouse SK, Anouti B, Akel R, Hanna NH, Adra N, Einhorn LH. Maintenance Oral Etoposide After High-Dose Chemotherapy (HDCT) for Patients With Relapsed Metastatic Germ-Cell Tumors (mGCT). Clin Genitourin Cancer. 2023 Apr;21(2):213-220. doi: 10.1016/j.clgc.2023.01.004. Epub 2023 Jan 18.(PubMed)