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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 Sequ

Brief Summary:

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.


Detailed Summary:

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.

PROJE
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Ototoxicity as measured by Common Toxicity Criteria (CTC) v3.0 [ Time Frame: Annually ]

Original Primary Outcome:

Current Secondary Outcome:

  • Neuroendocrine toxicity as measured by CTC v3.0 [ Time Frame: Annually ]
  • Neurocognitive toxicity as measured by CTC v3.0 [ Time Frame: Years 1, 2 and 5 ]


Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: March 15, 2005
Date Started: May 2002
Date Completion:
Last Updated: March 14, 2016
Last Verified: March 2016