Clinical trial · Interventional
Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
A Prospective Randomised Controlled Trial Of Hyperfractionated Versus Conventionally Fractionated Radiotherapy In Standard Risk Medulloblastoma
- 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: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways with combination chemotherapy may kill any remaining tumor cells following surgery. It is not yet known which radiation therapy regimen combined with combination chemotherapy is more effective in treating medulloblastoma. PURPOSE: Randomized phase III trial to compare different radiation therapy regimens plus combination chemotherapy in treating children who have undergone surgery for medulloblastoma.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| lomustine | Drug | Lomustine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Comparison of event-free survival at 3 years
Secondary outcomes (4)
- measure
- Comparison of overall survival
- measure
- Comparison of the pattern of relapse (i.e., local relapse [tumor bed and posterior fossa outside tumor bed])
- measure
- Comparison of late sequelae, in terms of health status, quality of life, hearing loss, and endocrine deficiencies
- measure
- Toxicity of neurosurgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed medulloblastoma, including the following variants: * Classic * Nodular/desmoplastic * Large cell * Melanotic * Medullomyoblastoma * Prior total or subtotal surgical removal of tumor within the past 28-40 days * No more than 1.5 cm\^2 residual tumor by early postoperative MRI or CT scan * No brainstem or supratentorial primitive neuroectodermal tumor * No atypical teratoid rhabdoid tumor * No known predisposition to medulloblastoma (e.g., Gorlin's syndrome) * No CNS metastasis (supratentorial, arachnoid of the posterior fossa, or craniospinal axis) by MRI * No clinical evidence of metastasis outside the CNS * No tumor cells in lumbar cerebrospinal fluid by cytospin PATIENT CHARACTERISTICS: Age * 3 to 21 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Hematological function less than CTC grade 2 Hepatic * Liver function less than CTC grade 2 Renal * Renal function less than CTC grade 2 Other * Not pregnant * Fertile patients must use effective contraception * Able to receive radiotherapy twice daily * Vital functions within age-appropriate normal range * Audiological function less than CTC grade 2 * No medical contraindication to radiotherapy or chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Concurrent dexamethasone as an antiemetic allowed, provided all other therapies have failed Radiotherapy * No concurrent cobalt irradiation Surgery * See Disease Characteristics Other * No prior treatment for brain tumor or any other malignancy
References
Publications (0)
Data not yet available