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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:
Information provided by (Responsible Party):
Nancy J. Tarbell, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00105560
First received: March 15, 2005
Last updated: October 15, 2014
Last verified: October 2014
  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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Ototoxicity as measured by Common Toxicity Criteria (CTC) v3.0 [ Time Frame: Annually ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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: October 15, 2014
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:
Central Nervous System Neoplasms
Medulloblastoma
Nervous System Neoplasms
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive

ClinicalTrials.gov processed this record on November 25, 2014