Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105560
Status:
COMPLETED
Last Update Posted:
2021-12-28
First Post:
2005-03-15
Brief Title:
Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase II Study of Craniospinal and Posterior Fossa Irradiation Using Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma Assessment of Acute and Long Term Sequelae
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MGH-99-271 | OTHER | Massachusetts General Hospital | httpsreporternihgovquickSearchP01CA021239 |
| P01CA021239 | NIH | None | None |