Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
Recruiting
Phase 2
Interventional Study
Germ Cell Tumor
Non-seminomatous Germ Cell Tumor
Ovarian Germ Cell Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 64 (estimated)
- Sponsor
- Nabil Adra · Other
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About This Trial
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Written informed consent and HIPAA authorization for release of personal health information
2. Age ≥ 18 years at the time of consent
3. Histological or serological evidence of non-seminomatous GCT
4. Relapsed disease after first-line cisplatin-based combination chemotherapy
5…
Contacts