Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00105560

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 Cancer-Related Problem/Condition	Procedure: adjuvant therapy Procedure: cognitive assessment Procedure: management of therapy complications Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Ototoxicity as measured by Common Toxicity Criteria (CTC) v3.0 annually [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Neuroendocrine toxicity as measured by CTC v3.0 annually [ Designated as safety issue: Yes ]
Neurocognitive toxicity as measured by CTC v3.0 at years 1, 2, and 5 [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	May 2002
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

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 45 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105560

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

Investigators

Study Chair:

Nancy J. Tarbell, MD

Massachusetts General Hospital

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):

long-term effects secondary to cancer therapy in children
untreated childhood medulloblastoma
untreated childhood pineoblastoma

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009