Brain and Central Nervous System Tumors Clinical Trial
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
Verified date | December 2021 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | December 2020 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 21 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Cancer Institute (NCI) |
United States,
Yock TI, Yeap BY, Ebb DH, Weyman E, Eaton BR, Sherry NA, Jones RM, MacDonald SM, Pulsifer MB, Lavally B, Abrams AN, Huang MS, Marcus KJ, Tarbell NJ. Long-term toxic effects of proton radiotherapy for paediatric medulloblastoma: a phase 2 single-arm study. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative Incidence of Ototoxicity | Percentage participants who experienced ototoxicity as measured by Common Toxicity Criteria for Adverse Events (CTCAE) v3.0 after the completion of radiation therapy in the overall participant population and by baseline measure subgroups. Incidence is shown after follow-up of 3 years, 5 years, 7 years, and 10 years. | 3 Years, 5 years, 7 years, 10 years | |
Secondary | Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 3 Years | Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 3 years of follow-up (as determined by CTCAE 3.0). Incidence is grouped by hormone type and risk group | 3 years | |
Secondary | Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 5 Years | Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 5 years of follow-up (as determined by CTCAE 3.0). Incidence is shown by hormone type and risk group. | 5 years | |
Secondary | Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years | Percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) after 7 years of follow-up, as determined by CTCAE 3.0. Incidence is shown by hormone type and risk group | 7 years | |
Secondary | Cumulative Incidence of Endocrine Dysfunction (Neuroendocrine and End Organ Defects) at 7 Years | percentage of participants who experienced endocrine dysfunction (neuroendocrine and end organ defects) as determined by CTCAE 3.0) at year 3, year 5, and year 7 of follow-up. | 3 years, 5 years, 7 years | |
Secondary | Mean Change Per-Year in Neurocognitive Outcomes | The mean change per-year in neurocognitive outcomes as assessed by Wechsler Intelligence Scale for Children version 4 (WISC-IV). The test measures the Full Scale Intelligence Quotient (FSIQ) of children with the use of four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale that has an average score of 100 and standard deviation of 15 points in the general population, meaning on average 68% of test takers would be within +/- 15 points of 100 and 95% within +/- 30 points. Higher scores represent higher intelligence and lower score represent reduced intelligence. Participants were assessed for changes in score with the use of repeated testing during a median follow-up time of 5.2 years. Repeated measures were taken at baseline, 1, 3, 5, and 7 years or until the participant was not available for evaluation (whichever comes first). | Baseline, 1, 3, 5, 7 years | |
Secondary | Progression Free Survival | The percentage of participants with progression free survival after five, seven, and ten years in the overall population and by risk and histological group. | 5 years, 7 years, 10 years | |
Secondary | Overall Survival | the percentage of participants surviving after five and seven years and at the end of follow-up in the overall population. Survival is shown by risk and histological group. | 5 years, 7 years, 10 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT00006080 -
Fenretinide in Treating Patients With Recurrent Malignant Glioma
|
Phase 2 | |
Recruiting |
NCT00887146 -
Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma
|
Phase 3 | |
Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
Completed |
NCT00621686 -
Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme
|
Phase 2 | |
Terminated |
NCT00227032 -
Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme
|
Phase 1 | |
Completed |
NCT00112502 -
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
|
Phase 2 | |
Terminated |
NCT00243022 -
Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
|
Phase 2 | |
Active, not recruiting |
NCT00278278 -
Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas
|
Phase 3 | |
Active, not recruiting |
NCT00087815 -
Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain
|
N/A | |
Completed |
NCT00416819 -
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
|
N/A | |
Completed |
NCT00052286 -
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
|
N/A | |
Completed |
NCT00006093 -
EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
|
Phase 1/Phase 2 | |
Recruiting |
NCT00004129 -
Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
|
Phase 1 | |
Completed |
NCT00004212 -
DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Completed |
NCT00003417 -
Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme
|
Phase 1/Phase 2 | |
Completed |
NCT00008008 -
Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma
|
Phase 2 | |
Completed |
NCT00003484 -
Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors
|
Phase 1 | |
Completed |
NCT00003173 -
High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
|
Phase 2 | |
Completed |
NCT00003020 -
LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases
|
Phase 1 |