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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nancy J. Tarbell, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00105560
First received: March 15, 2005
Last updated: May 2, 2012
Last verified: May 2012
History of Changes

March 15, 2005
May 2, 2012
May 2002
December 2014   (final data collection date for primary outcome measure)
Ototoxicity as measured by Common Toxicity Criteria (CTC) v3.0 [ Time Frame: Annually ] [ Designated as safety issue: No ]
Ototoxicity as measured by Common Toxicity Criteria (CTC) v3.0 annually
Complete list of historical versions of study NCT00105560 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Neuroendocrine toxicity as measured by CTC v3.0 annually
  • Neurocognitive toxicity as measured by CTC v3.0 at years 1, 2, and 5
 
 
 
Proton Beam Radiation Therapy in Treating Young Patients Who Have Undergone Biopsy or Surgery for Medulloblastoma or Pineoblastoma
Phase II Study of Craniospinal and Posterior Fossa Irradiation Using Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: Assessment of Acute and Long Term Sequelae

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.

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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Long-term Effects Secondary to Cancer Therapy in Children
Radiation: radiation therapy
Radiation therapy with proton beam to standard doses
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
 
December 2014   (final data collection date for primary outcome measure)

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
Both
3 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105560
CDR0000415841, P01CA021239, MGH-99-271
Yes
Nancy J. Tarbell, M.D., Massachusetts General Hospital
Massachusetts General Hospital
National Cancer Institute (NCI)
Study Chair: Nancy J. Tarbell, MD Massachusetts General Hospital
Massachusetts General Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP