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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
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.
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States
RECRUITING12-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)
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
Toxicities according to CTCAE v5 will be summarized by frequencies and rates calculated as the proportion of patients in the safety population experiencing SAEs, discontinuations due to AEs, and AEs.
Time frame: through study completion (i.e. up to 2 years)
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