Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

This study is currently recruiting participants.
Verified April 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: April 10, 2014
Last verified: April 2014

February 3, 2010
April 10, 2014
April 2010
April 2018   (final data collection date for primary outcome measure)
  • 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
  • To estimate the incidence and severity of ototoxicity at three years following the completion of radiation therapy. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To describe the incidence of endocrine dysfunction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To describe the incidence and severity of neurocognitive sequelae overall and in subgroups based on whether or not methotrexate was used as part of the treatment regimen [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01063114 on ClinicalTrials.gov Archive Site
  • 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.
  • To determine the 3-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To develop a new supine technique to improve the speed of treating patients requiring cranial spinal irradiation and improve the safety of treating patients under anesthesia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the acute side effects from CSI using proton beam therapy, including nausea, esophagitis, and weight loss. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma
Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: An Assessment of Acute Toxicity and Long Term Neurocognitive, Neuroendocrine and Ototoxicity Outcomes

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.

  • 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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain Tumor
  • Medulloblastoma
  • Pineoblastoma
Radiation: proton beam radiation
Given once a day, 5 days a week (Monday-Friday)
Experimental: Proton Beam Radiation
Proton Beam Radiation
Intervention: Radiation: proton beam radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
April 2024
April 2018   (final data collection date for primary outcome measure)

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 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 disease
  • Patients with prior radiation therapy
  • Any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements
  • Pregnant women
Both
3 Years to 25 Years
No
Contact: Torunn I Yock, MD 617-726-5184 tyock@partners.org
United States
 
NCT01063114
09-361, P01CA021239
Yes
Torunn Yock, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Principal Investigator: Torunn I Yock, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2014

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