Clinical trial · Interventional
Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial
- 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)
This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with 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 |
|---|---|---|---|
| Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Craniospinal Irradiation | Radiation | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Involved-Field Radiation Therapy | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Lomustine | Drug | Lomustine | ALIAS |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Arm I (3-7 years of age, LDCSI, IFRT)
- description
- See Detailed Description (Arm I)
- interventionNames
- Drug: Cisplatin
- Radiation: Craniospinal Irradiation
- Drug: Cyclophosphamide
- Radiation: Involved-Field Radiation Therapy
- Other: Laboratory Biomarker Analysis
- Drug: Lomustine
- Other: Quality-of-Life Assessment
- Drug: Vincristine Sulfate
- type
- EXPERIMENTAL
- label
- Arm II (3-7 years of age, LDCSI, PFRT)
- description
- See Detailed Description (Arm II)
- interventionNames
- Drug: Cisplatin
- Radiation: Craniospinal Irradiation
- Drug: Cyclophosphamide
- Other: Laboratory Biomarker Analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed medulloblastoma located in the posterior fossa
* Standard-risk disease
* Minimal volume, non-disseminated disease, defined by the following:
* Residual tumor ≤ 1.5 cm\^2 confirmed by MRI with contrast imaging within 21 days after surgery
* No metastatic disease in the head, spine, or cerebrospinal fluid (CSF) confirmed by both of the following:
* Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery
* Negative cytological examination of CSF after surgery, but before study enrollment
* Brain stem involvement allowed
* Performance status - Karnofsky 50-100% (\> 16 years of age)
* Performance status - Lansky 30-100% (≤ 16 years of age)
* Absolute neutrophil count \> 1,500/uL
* Platelet count \> 100,000/uL (transfusion independent)
* Hemoglobin \> 10 g/dL (transfusions allowed)
* Bilirubin \< 1.5 times upper limit of normal (ULN) for age
* AST or ALT \< 1.5 times ULN for age
* Creatinine clearance OR radioisotope glomerular filtration rate \>= 70 mL/min/1.73m\^2 or a serum creatinine based on age/gender as follows:
Age Maximum Serum Creatine (mg/dL)
* 1month to \< 6 months male: 0.4 female: 0.4
* 6 months to \<1 year male: 0.5 female: 0.5
* 1 year to \< 2 years male: 0.6 female: 0.6
* 2 to \< 6 years male: 0.8 female: 0.8
* 6 to \< 10 years male: 1 female: 1
* 10 to \< 13 years male: 1.2 female: 1.2
* 13 to \< 16 years male: 1.5 female: 1.4
* \>= 16 years male: 1.7 female: 1.4
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior chemotherapy
* Prior corticosteroids allowed
* No prior radiotherapyReferences
Publications (1)
- DERIVEDMichalski JM, Janss AJ, Vezina LG, Smith KS, Billups CA, Burger PC, Embry LM, Cullen PL, Hardy KK, Pomeroy SL, Bass JK, Perkins SM, Merchant TE, Colte PD, Fitzgerald TJ, Booth TN, Cherlow JM, Muraszko KM, Hadley J, Kumar R, Han Y, Tarbell NJ, Fouladi M, Pollack IF, Packer RJ, Li Y, Gajjar A, Northcott PA. Children's Oncology Group Phase III Trial of Reduced-Dose and Reduced-Volume Radiotherapy With Chemotherapy for Newly Diagnosed Average-Risk Medulloblastoma. J Clin Oncol. 2021 Aug 20;39(24):2685-2697. doi: 10.1200/JCO.20.02730. Epub 2021 Jun 10. PMID 34110925