Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 Long-term Effects Secondary to Cancer Therapy in Children |
Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Ototoxicity as measured by Common Toxicity Criteria (CTC) v3.0 [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Neuroendocrine toxicity as measured by CTC v3.0 [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Neurocognitive toxicity as measured by CTC v3.0 [ Time Frame: Years 1, 2 and 5 ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | May 2002 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Radiation therapy
This is a single arm study of radiation therapy with protons to standard doses.
|
Radiation: radiation therapy
Radiation therapy with proton beam to standard doses
|
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.
Eligibility| 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
- 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
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Study Chair: | Nancy J. Tarbell, MD | Massachusetts General Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Nancy J. Tarbell, M.D., Attending Radiation Oncologist, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00105560 History of Changes |
| Other Study ID Numbers: | CDR0000415841, P01CA021239, MGH-99-271 |
| Study First Received: | March 15, 2005 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
long-term effects secondary to cancer therapy in children untreated childhood medulloblastoma untreated childhood pineoblastoma |
Additional relevant MeSH terms:
|
Medulloblastoma Nervous System Neoplasms Central Nervous System Neoplasms Pinealoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neuroectodermal Tumors, Primitive Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Brain Neoplasms Brain Diseases Central Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013