Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT (NCT04804007) | Clinical Trial Compass
RecruitingPhase 2
Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
United States64 participantsStarted 2021-03-03
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent and HIPAA authorization for release of personal health information
✓. Age ≥ 18 years at the time of consent
✓. Histological or serological evidence of non-seminomatous GCT
✓. Relapsed disease after first-line cisplatin-based combination chemotherapy
✓. Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines
✓. HDCT must have been used as the initial salvage chemotherapy regimen (2nd line therapy) 6.1. Note: 1 or 2 cycles of standard course regimens prior to HDCT are acceptable (regimens include VeIP \[vinblastine+ifosfmaide+cisplatin\] or TIP \[paclitaxel+ifosfamide+cisplatin\] or PVB \[cisplatin+vinblastine+bleomycin\]
✓. Normal or declining tumor markers (AFP and hCG) at time of screening
✓. Adverse events from prior therapy recovered to CTCAE v5.0 grade ≤ 2 at time of registration
Exclusion criteria
✕. Relapsed pure seminoma
✕. Rising tumor markers (AFP and hCG) at time of screening
✕. Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) \>16 weeks ago
✕. Treatment with any investigational agent within 28 days prior to study registration
What they're measuring
1
12-month Progression Free Survival
Timeframe: time from the date of randomization to the date of disease relapse or death (i.e. up to 1 year)