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Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01063114
Recruitment Status : Active, not recruiting
First Posted : February 5, 2010
Last Update Posted : January 9, 2023
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital

Study Description
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Brief Summary:
There are two types of external radiation treatments (proton beam and photon beam). As part of the participant's treatment, they will receive radiation to the entire central nervous system (CNS); this is known as craniospinal irradiation (CSI). In the past, photon radiation therapy has been used for CSI. In this study we will be examining the effects of proton beam radiation therapy. Studies have suggested that this kind of radiation can cause less damage to normal tissue than photon radiation therapy. The physical characteristics of proton beam radiation let the doctor safely deliver the amount of radiation delivered to the tumor that is normally delivered through standard therapy but spare more normal tissue in the process.

Condition or disease Intervention/treatment Phase
Brain Tumor Medulloblastoma Pineoblastoma Radiation: proton beam radiation Not Applicable

Detailed Description:
  • Before beginning radiation therapy, participants will have scans done in order to prepare for the radiation treatment. Doctors will use information gathered from these scans to plan the best way to deliver radiation to the tumor.
  • The following procedures will be performed either before or during the radiotherapy: Hearing exam; neurocognitive exam; blood tests and cerebral spinal fluid test.
  • Not everyone who participates in this study will receive the same amount of proton radiation therapy. The length of time and amount of radiation received will depend upon the condition of the participant's disease. Radiation treatment will be given once a day, 5 days a week (Monday-Friday). The overall treatment course will be approximately 6 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: An Assessment of Acute Toxicity and Long Term Neurocognitive, Neuroendocrine and Ototoxicity Outcomes
Actual Study Start Date : April 2010
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Proton Beam Radiation
Proton Beam Radiation
 Radiation: proton beam radiation
Given once a day, 5 days a week (Monday-Friday)


Outcome Measures
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Primary Outcome Measures :
  1. Ototoxicity [ Time Frame: 3 years ]
    Incidence and severity of ototoxicity at three years following the completion of radiation therapy.

  2. Endocrine dysfunction [ Time Frame: 3 years ]
    Incidence and severity of endocrine dysfunction at three years following completion of proton radiation therapy.

  3. Neurocognitive Effects [ Time Frame: 3 years ]
    Incidence and severity of neurocognitive sequelae overall and in subgroups based on whether or not methotrexate was used as part of the treatment regimen


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 3 years ]
    3-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment.

  2. Treatment efficiency [ Time Frame: 2 years ]
    Speed of treating patients requiring cranial spinal irradiation and improve the safety of treating patients under anesthesia

  3. Acute toxicity [ Time Frame: 2 years ]
    Frequency and severity of acute side effects from CSI using proton beam therapy, including nausea, esophagitis, and weight loss.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have undergone biopsy or attempted surgical resection and must have histologically confirmed medulloblastoma or pineoblastoma.
  • Participants may have had a gross total resection, sub-total resection or biopsy only.
  • For patients with no prior chemotherapy, treatment must start within 35 days of definitive surgery or as indicated if enrolled on therapeutic study
  • Age range between 3 and 25 at the time of enrollment
  • Life expectancy of greater than 3 months
  • Blood laboratory values as outlined in the protocol
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

  • Patients with more than one previous chemotherapy regimen
  • Patients with recurrent or progressive disease after one or more regimens of pre-radiation chemotherapy
  • Patients with prior radiation therapy
  • Any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements
  • Pregnant women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063114


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Massachusetts General Hospital
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Torunn I Yock, MD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01063114    
Other Study ID Numbers: 09-361
P01CA021239 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: January 2023
Keywords provided by Torunn Yock, MD, Massachusetts General Hospital:
proton beam radiation
Additional relevant MeSH terms:
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Medulloblastoma
Brain Neoplasms
Pinealoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue