Clinical trial · Interventional
Low-Dose Radiation and Combination Chemotherapy Following Surgery in Children With Newly Diagnosed Medulloblastoma
Study Of Reduced Dose Craniospinal Radiotherapy (1800 cGy) And Chemotherapy In Children With Newly-Diagnosed Standard-Risk Posterior Fossa Primitive Neuro-ectodermal Tumor (PNET/Medulloblastoma)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated prematurely due to slow accrual.
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, but also damages normal cells in the developing brains of children. Combining low-dose radiation therapy in combination with chemotherapy should be effective in treating medulloblastoma while avoiding the long-term side effects of giving higher dose radiation to children with newly diagnosed average risk medulloblastoma.
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 |
|---|---|---|---|
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Tumors | Central Nervous System Neoplasm | ALIAS | 0.90 |
| Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Craniospinal Radiation | Radiation | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Lomustine | Drug | Lomustine | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Treatment
- description
- All subjects will undergo routine surgical staging of their tumor. Treatment must begin within 28 days of surgery. Craniospinal Radiation therapy will last for 6 weeks, five days per week. Once a week during radiation, subjects will also be treated with vincristine. 4 weeks after radiation and vincristine treatment is completed, all subjects will begin 9 cycles (each cycle lasts 6 weeks) of "maintenance chemotherapy" which will be given as 2 different drug combinations, Regimen A (Lomustine, Vincristine, and Cisplatin) and Regimen B (Cyclophosphamide, given with Mesna, and Etoposide \[IV and oral\]) which will be given in the following order: AABAABAAB (total of 54 weeks).
- interventionNames
- Drug: Cisplatin
- Drug: Cyclophosphamide
- Drug: Etoposide
- Drug: Lomustine
- Drug: Vincristine
- Radiation: Craniospinal Radiation
Primary outcomes (1)
- measure
- Evaluate Rate of Late Neurotoxic Effects
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed medulloblastoma 2. Standard-risk disease 3. No residual tumor greater than 1.5 cm\^2 after resection by postoperative MRI * No tumor in the spinal or cerebral subarachnoid space by MRI * No tumor in the subarachnoid space by Cerebrospinal fluid (CSF) * No failure to perform staging studies (spine MRI and CSF cytology) preoperatively or postoperatively 4. Must begin radiotherapy on study within 28 days after surgery Exclusion Criteria: 1. Prior radiotherapy and anti-tumor chemotherapy other than corticosteroids are not allowed. 2. Pregnant females will not be eligible 3. Patients must begin radiotherapy on protocol within 28 days of completion of surgery. Exceptions need to be approved by the Principal Investigator. 4. Patients with the following will not be eligible: * \> 1.5cm3 residual tumor following resection as indicated by post-operative MRI. * tumor in spinal or cerebral subarachnoid space either by MRI of brain and spine * tumor in subarachnoid space by CSF cytology * failure to perform staging studies (spine MRI, CSF cytology) either pre- or post- operatively
References
Publications (1)
- DERIVEDMinturn JE, Mochizuki AY, Partap S, Belasco JB, Lange BJ, Li Y, Phillips PC, Gibbs IC, Fisher PG, Fisher MJ, Janss AJ. A Pilot Study of Low-Dose Craniospinal Irradiation in Patients With Newly Diagnosed Average-Risk Medulloblastoma. Front Oncol. 2021 Sep 2;11:744739. doi: 10.3389/fonc.2021.744739. eCollection 2021. PMID 34540703