Clinical trial · Interventional
Combination Chemotherapy and Radiation Therapy in Treating Patients With Germ Cell Tumors in the Brain
SIOP Intracranial Germ Cell Tumours Protocol
- 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)
RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, ifosfamide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells. PURPOSE: This phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to radiation therapy alone in treating patients with germ cell tumors in the brain.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Survival
- measure
- Event-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Clinical and radiological evidence of intracranial germ cell tumor, classified as 1 of the following:
* Germinoma
* Pure germinoma
* Germinoma with mature and/or immature teratoma
* Secreting germ cell tumor
* Elevated tumor markers in serum and/or cerebral spinal fluid as evidenced by any of the following:
* Alpha-fetoprotein \> 25 ng/mL
* β-human choriogonadotropin \> 50 IU/L
* Any tumor containing 1 of these components:
* Yolk sac tumor
* Choriocarcinoma
* Embryonal tumor
* Normal tumor markers allowed
* Diagnosis confirmed by histology or elevated serum markers
* Metastatic or nonmetastatic disease
* Two separate tumors in the suprasellar and pineal areas without evidence of metastatic disease elsewhere are considered nonmetastatic multifocal disease
* Study treatment must begin ≤ 4 weeks after diagnosis
* No pure immature or mature teratomas
* The following additional patients are eligible:
* Patients who are \> 18 years of age provided no other appropriate protocol exists
* Patients who were diagnosed \> 4 weeks ago
* Patients who are in relapse
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* No prior treatment except surgery
* No concurrent amino glycosides or other nephrotoxic drugs during ifosfamide administration
* No concurrent growth factors
* No other concurrent chemotherapy or radiotherapyReferences
Publications (1)
- DERIVEDRajagopal R, Leong SH, Jawin V, Foo JC, Ahmad Bahuri NF, Mun KS, Azman RR, Loh J, Yap TY, Ariffin H, Moreira DC, Gottardo NG, Bouffet E, Ganesan D. Challenges in the Management of Childhood Intracranial Germ Cell Tumors in Middle-Income Countries: A 20-Year Retrospective Review From a Single Tertiary Center in Malaysia. J Pediatr Hematol Oncol. 2021 Oct 1;43(7):e913-e923. doi: 10.1097/MPH.0000000000002116. PMID 33633029