Clinical trial · Observational
Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy
CCLG Observational Study of the Outcome of Ependymoma in Infants Diagnosed Before Their Third Birthday
NCT00683319CI-TRIAL-00012250active not recruitingClinicalTrials.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)
RATIONALE: Gathering information about how young patients with ependymoma respond to standard combination chemotherapy and learning about the long-term effects of this treatment may help doctors plan better treatment. PURPOSE: This phase III trial is observing young patients with ependymoma undergoing standard combination chemotherapy.
Conditions
Conditions (4)
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 | — | UNRESOLVED | — |
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Long-term Effects Secondary to Cancer Therapy in Children | — | UNRESOLVED | — |
| Ototoxicity | — | UNRESOLVED | — |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| cognitive assessment | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| magnetic resonance spectroscopic imaging | Procedure | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Overall survival
- measure
- Event-free survival
- measure
- Response to chemotherapy, if there is residual disease
- measure
- Requirement for radiotherapy (i.e., residual disease at the completion of chemotherapy, progressive disease during chemotherapy, or recurrent disease during or after completion chemotherapy)
- measure
- Late effects of treatment (i.e., ototoxicity and nephrotoxicity at the completion of chemotherapy and neurocognitive outcomes at 5, 7, 11, and 16 years of age)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 2 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed WHO grade 3 anaplastic (malignant) ependymoma or WHO grade 2 ependymoma, including the following variants:
* Papillary
* Cellular
* Clear cell
* Tanycytic
* No myxopapillary ependymoma, subependymoma, or ependymoblastoma
* Meets 1 of the following criteria:
* Has undergone complete resection of the primary tumor (prior to starting chemotherapy)
* Two or more surgical procedures to achieve complete resection allowed
* Metastatic disease at diagnosis (with or without complete resection of the primary tumor)
* Unable to undergo complete resection of the primary tumor (with or without metastatic disease)
* Patients with measurable residual disease (primary or metastatic disease) are eligible provided they undergo treatment on clinical trial CCLG-CNS-2005-03 prior to entering this study
* Has undergone surgical resection OR completed treatment on clinical trial CCLG-CNS-2005-03 within the past 3 weeks
* Patients who are unable to tolerate chemotherapy or who do not receive treatment according to the CCLG guidelines for ependymoma due to parental preference or recommendation from the treating physician are eligible
PATIENT CHARACTERISTICS:
* Able to tolerate IV hydration
* No active infection
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (0)
Data not yet available
No reference posted for this study.