Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 3 - 21 |
| Updated: | 12/20/2018 |
| Start Date: | May 2002 |
| End Date: | December 2021 |
Phase II Study of Craniospinal and Posterior Fossa Irradiation Using Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: Assessment of Acute and Long Term Sequelae
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.
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.
OBJECTIVES:
- Determine the 3-year incidence and severity of ototoxicity in young patients with
medulloblastoma or pineoblastoma treated with adjuvant proton beam craniospinal and
posterior fossa radiotherapy.
- Determine the incidence of primary hypothyroidism and other endocrine dysfunction
(neuroendocrine and end organ) in patients treated with this regimen.
- Determine the incidence and severity of neurocognitive abnormalities in patients treated
with this regimen.
- Determine the acute side effects of this regimen, including esophagitis, upper and lower
gastrointestinal tract disease, and weight loss, in these patients.
- Determine the 3-year progression-free survival rate of patients treated with this
regimen.
OUTLINE: Patients are stratified according to risk (standard vs high).
Patients receive proton beam craniospinal and posterior fossa radiotherapy once daily 5 days
a week for 6-8 weeks*.
NOTE: *Unless otherwise specified by a co-existing protocol.
Patients undergo neurocognitive evaluation at baseline or within 3 months after completion of
radiotherapy and then at 1, 3, and 5 years. Patients also undergo endocrine evaluation at
baseline and then annually for 5 years; and audiology evaluation at baseline, before each
course of cisplatin-based chemotherapy (if receiving this), and then annually for 5 years.
After completion of study treatment, patients are followed every 3-6 months for 2-5 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
- Determine the 3-year incidence and severity of ototoxicity in young patients with
medulloblastoma or pineoblastoma treated with adjuvant proton beam craniospinal and
posterior fossa radiotherapy.
- Determine the incidence of primary hypothyroidism and other endocrine dysfunction
(neuroendocrine and end organ) in patients treated with this regimen.
- Determine the incidence and severity of neurocognitive abnormalities in patients treated
with this regimen.
- Determine the acute side effects of this regimen, including esophagitis, upper and lower
gastrointestinal tract disease, and weight loss, in these patients.
- Determine the 3-year progression-free survival rate of patients treated with this
regimen.
OUTLINE: Patients are stratified according to risk (standard vs high).
Patients receive proton beam craniospinal and posterior fossa radiotherapy once daily 5 days
a week for 6-8 weeks*.
NOTE: *Unless otherwise specified by a co-existing protocol.
Patients undergo neurocognitive evaluation at baseline or within 3 months after completion of
radiotherapy and then at 1, 3, and 5 years. Patients also undergo endocrine evaluation at
baseline and then annually for 5 years; and audiology evaluation at baseline, before each
course of cisplatin-based chemotherapy (if receiving this), and then annually for 5 years.
After completion of study treatment, patients are followed every 3-6 months for 2-5 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
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
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