N/A
Completed N=59
Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma
Brain Cancer · Long-term Effects Secondary to Cancer Therapy in Children
Source: ClinicalTrials.gov NCT00105560 ↗
Enrolled (actual)
59
Serious AEs
22.0%
Results posted
Aug 2017
Primary outcomePrimary: Cumulative Incidence of Ototoxicity — 12; 16; 16; 15 percentage of participants
Summary
RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well proton beam radiation therapy works in treating young patients who have undergone biopsy or surgery for medulloblastoma or pineoblastoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Incidence of Ototoxicity |
12; 16; 16; 15; 20; 20 | — |
| SECONDARY Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years |
27; 28; 25; 22; 23; 20 | — |
| SECONDARY Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years |
55; 58; 50; 46; 50; 40 | — |
| SECONDARY Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years |
27; 55; 63; 22; 46; 55 | — |
| SECONDARY Mean Change Per-Year in Neurocognitive Outcomes |
-1.5; -1.3; -.4; -0.8; -2.4 | — |
| SECONDARY Progression Free Survival |
80; 75; 85; 81; 70; 63 | — |
| SECONDARY Overall Survival |
83; 81; 86; 86; 75; 68 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed medulloblastoma or pineoblastoma
- Standard-risk or high-risk disease
- Must have undergone biopsy or attempted surgical resection of the tumor within the past 35 days
- Requires craniospinal irradiation
PATIENT CHARACTERISTICS:
Age
- 3 to 21
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No more than 1 prior chemotherapy regimen
- No prior IV or intrathecal methotrexate
- No prior intrathecal thiotepa
- Concurrent cisplatin-based chemotherapy, including chemotherapy administered on another study, allowed
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
Data sourced from ClinicalTrials.gov (NCT00105560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.