OncoMatch/Clinical Trials/NCT04804007
Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
Is NCT04804007 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Etoposide for germ cell tumor.
Treatment: Etoposide — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Testicular Germ Cell Tumor
Ovarian Cancer
Biomarker criteria
Required: AFP normal or declining (normal or declining)
Normal or declining tumor markers (AFP and hCG) at time of screening
Required: CGB normal or declining (normal or declining)
Normal or declining tumor markers (AFP and hCG) at time of screening
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cisplatin-based combination chemotherapy (cisplatin) — first-line
Relapsed disease after first-line cisplatin-based combination chemotherapy
Must have received: high-dose chemotherapy and peripheral blood stem cell transplant — salvage (2nd line)
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)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1,000 /mcL; Platelets ≥100,000 / mcL; Hemoglobin ≥8 g/dL
Kidney function
Serum creatinine <2mg/dL
Liver function
Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR 5 X ULN for subjects with liver metastases
Adequate organ function lab values obtained within 28 days prior to study registration
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Indiana University Melvin & Bren Simon Cancer Center · Indianapolis, Indiana
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04804007 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received cisplatin-based combination chemotherapy and high-dose chemotherapy and peripheral blood stem cell transplant.
Does this trial require AFP?
Yes, AFP normal or declining is a required biomarker for enrollment.
Does this trial require CGB?
Yes, CGB normal or declining is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify