Clinical trial · Interventional
Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors
Protocol for the Treatment of Extracranial Germ Cell Tumours in Children and Adolescents (GC III)
- 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: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This phase III trial is studying how well observation and/or combination chemotherapy works after surgery or biopsy in treating young patients with extracranial germ cell tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Germ Cell Tumor | Childhood Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| bleomycin sulfate | Biological | Bleomycin | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| etoposide | Drug | Etoposide | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| vinblastine sulfate | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Event-free survival
- measure
- Continuation of treatment
- measure
- Development of common and follow-up strategies
- measure
- Registration of all cases of mature and immature teratoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically\* proven extracranial malignant germ cell tumor (GCT), including mature/immature teratoma, with or without elevated alpha-fetoprotein (AFP) or human chorionic gonadotropin (HCG) levels
* Newly diagnosed disease
* Patients with relapsed or progressive extracranial malignant GCT allowed if previously treated with carboplatin, etoposide, and bleomycin (JEB) chemotherapy
* Patients relapsing following JEB are eligible for the study relapse strategy NOTE: \*Patients with unequivocally raised AFP/HCG whose risk of biopsy is felt to be high can be diagnosed by clinical grounds, imaging, and markers
* No intracranial GCTs
PATIENT CHARACTERISTICS:
* Neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* ALT ≤ 3 times ULN
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy other than JEBReferences
Publications (0)
Data not yet available