Clinical trial · Interventional
Reduced Dose Radiotherapy Following High Dose Chemotherapy in Intracranial Non-germinomatous Germ Cell Tumor
Reduced-dose Radiotherapy Following High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Central Nervous System Non-germinomatous Germ Cell Tumors
NCT02784054CI-TRIAL-00044139unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and autologous stem cell transplantation (HDCT/auto-SCT).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intracranial Non-germinomatous Germ Cell Tumor | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin | Drug | Bleomycin | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Reduced dose radiotherapy | Radiation | — | UNRESOLVED |
| Thiotepa | Drug | Thiotepa | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intracranial NGGCT
- description
- 1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen. 2. Peripheral blood stem cell collection during the first cycle of chemotherapy. 3. Surgery, if there is residual tumor after chemotherapy. 4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT) * 1st HDCT: Carboplatin, thiotepa, etoposide * 2nd HDCT: Cyclophosphamide, melphalan 5. Reduced dose of radiotherapy
- interventionNames
- Drug: Carboplatin
- Drug: Etoposide
- Drug: Cyclophosphamide
- Drug: Bleomycin
- Drug: Thiotepa
- Drug: Melphalan
- Radiation: Reduced dose radiotherapy
Primary outcomes (1)
- measure
- Rate of event free survival
- timeFrame
- Up to 3 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pathologically proven intracranial non-germinomatous germ cell tumor or * Patients who have brain mass which are suspected as intracranial germ cell tumor and elevated serum or cerebrospinal fluid alpha-feto protein. Exclusion Criteria: * Patients with organ dysfunction (ejection fraction \<40%, creatinine \> 3 x upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransaminase \> 5 x ULN). * Pregnant or nursing women
References
Publications (0)
Data not yet available
No reference posted for this study.