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Sponsors and Collaborators: |
Massachusetts General Hospital National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00105560 |
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.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Cancer-Related Problem/Condition |
Procedure: adjuvant therapy Procedure: cognitive assessment Procedure: management of therapy complications Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Estimated Enrollment: | 45 |
Study Start Date: | May 2002 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 45 patients will be accrued for this study.
Ages Eligible for Study: | 3 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed medulloblastoma or pineoblastoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 |
Study Chair: | Nancy J. Tarbell, MD | Massachusetts General Hospital |
Study ID Numbers: | CDR0000415841, MGH-99-271 |
Study First Received: | March 15, 2005 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00105560 |
Health Authority: | Unspecified |
long-term effects secondary to cancer therapy in children untreated childhood medulloblastoma untreated childhood pineoblastoma |
Neuroectodermal Tumors, Primitive Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Neuroectodermal Tumors Brain Neoplasms Neoplasms, Germ Cell and Embryonal |
Neoplasm Metastasis Medulloblastoma Neuroepithelioma Glioma Pinealoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |