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OncoMatch/Clinical Trials/NCT04804007

Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT

Is NCT04804007 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Etoposide for germ cell tumor.

Phase 2RecruitingNabil AdraNCT04804007Data as of May 2026

Treatment: EtoposideThis 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).

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Extracted eligibility criteria

Cancer type

Testicular Germ Cell Tumor

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 2 prior lines

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 — salvage

Completed salvage treatment with HDCT and PBSCT for 2 tandem cycles per Institutional Guidelines

Cannot have received: investigational agent

Treatment with any investigational agent within 28 days prior to study registration

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 →

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