Clinical trial · Interventional
Combination Chemotherapy Followed by Second-Look Surgery and Radiation Therapy in Treating Children With Nonmetastatic Medulloblastoma or Primitive Neuroectodermal Tumor
Systemic Chemotherapy, Second Look Surgery and Conformal Radiation Therapy Limited to the Posterior Fossa and Primary Site for Children >/= to 8 Months and <3 Years With Non-metastatic Medulloblastoma: A Children&Apos;s Oncology Group Phase III Study
- 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 phase III trial is studying how well combination chemotherapy followed by second-look surgery and radiation therapy works in treating children with nonmetastatic medulloblastoma or primitive neuroectodermal tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with surgery and radiation therapy may kill more tumor cells.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Untreated Childhood Medulloblastoma | Childhood Medulloblastoma | CURATED_BROADER | 0.78 |
| Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor | Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Chemotherapy, surgery, radiation therapy
- description
- Patients receive induction chemotherapy consisting of vincristine sulfate IV on days 1, 8, and 15; cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses. After completion of induction chemotherapy, patients with residual disease undergo a therapeutic conventional surgery (second resection). Within 4 weeks after completion of induction chemotherapy or second resection, patients receive 3-dimensional conformal radiation therapy daily, 5 days a week, for 6 weeks. Four weeks after completion of 3-dimensional conformal radiation therapy, patients receive alternating treatments of maintenance chemotherapy. Patients receive vincristine sulfate IV on days 1, 8, and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses.
- interventionNames
- Drug: cisplatin
- Drug: cyclophosphamide
- Drug: vincristine sulfate
- Drug: etoposide
- Procedure: therapeutic conventional surgery
- Radiation: 3-dimensional conformal radiation therapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 3 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary medulloblastoma or posterior fossa primitive neuroectodermal tumor * Prior definitive tumor resection within 6 weeks of study * No evidence of metastases * Hemoglobin at least 10 g/dL * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * AST less than 2.5 times normal * Bilirubin less than 1.5 mg/dL * Creatinine less than 1.2 mg/dL * Creatinine clearance greater than 70 mL/min * No prior chemotherapy * No prior radiotherapy * See Disease Characteristics
References
Publications (0)
Data not yet available