Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01063114
First received: February 3, 2010
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Brain Tumor
Medulloblastoma
Pineoblastoma
Radiation: proton beam radiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Ototoxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Incidence and severity of ototoxicity at three years following the completion of radiation therapy.

  • Endocrine dysfunction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Incidence and severity of endocrine dysfunction at three years following completion of proton radiation therapy.

  • Neurocognitive Effects [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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:
  • Progression Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    3-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment.

  • Treatment efficiency [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Speed of treating patients requiring cranial spinal irradiation and improve the safety of treating patients under anesthesia

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


Estimated Enrollment: 90
Study Start Date: April 2010
Estimated Study Completion Date: April 2024
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Beam Radiation
Proton Beam Radiation
Radiation: proton beam radiation
Given once a day, 5 days a week (Monday-Friday)

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.
  Eligibility

Ages Eligible for Study:   3 Years to 25 Years
Genders Eligible for Study:   Both
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
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: NCT01063114

Contacts
Contact: Torunn I Yock, MD 617-726-5184 tyock@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Torunn I Yock, MD       tyock@partners.org   
Principal Investigator: Torunn I Yock, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Anita Mahajan, M.D.       amahajan@mdanderson.org   
Principal Investigator: Anita Mahajan, MD         
Sponsors and Collaborators
Massachusetts General Hospital
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Torunn I Yock, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Torunn Yock, MD, Director, Pediatric Radiation Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01063114     History of Changes
Other Study ID Numbers: 09-361, P01CA021239
Study First Received: February 3, 2010
Last Updated: October 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
proton beam radiation

Additional relevant MeSH terms:
Medulloblastoma
Pinealoma
Brain Diseases
Brain Neoplasms
Central Nervous System Diseases
Central 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
Nervous System Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive

ClinicalTrials.gov processed this record on November 20, 2014