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Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

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ClinicalTrials.gov Identifier: NCT01063114
Recruitment Status : Active, not recruiting
First Posted : February 5, 2010
Last Update Posted : August 18, 2020
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Torunn Yock, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE February 3, 2010
First Posted Date  ICMJE February 5, 2010
Last Update Posted Date August 18, 2020
Actual Study Start Date  ICMJE April 2010
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2012)
  • Ototoxicity [ Time Frame: 3 years ]
    Incidence and severity of ototoxicity at three years following the completion of radiation therapy.
  • Endocrine dysfunction [ Time Frame: 3 years ]
    Incidence and severity of endocrine dysfunction at three years following completion of proton radiation therapy.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2010)
  • To estimate the incidence and severity of ototoxicity at three years following the completion of radiation therapy. [ Time Frame: 3 years ]
  • To describe the incidence of endocrine dysfunction [ Time Frame: 3 years ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2012)
  • Progression Free Survival [ Time Frame: 3 years ]
    3-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment.
  • Treatment efficiency [ Time Frame: 2 years ]
    Speed of treating patients requiring cranial spinal irradiation and improve the safety of treating patients under anesthesia
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2010)
  • To determine the 3-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment. [ Time Frame: 3 years ]
  • 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 ]
  • To evaluate the acute side effects from CSI using proton beam therapy, including nausea, esophagitis, and weight loss. [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma
Official Title  ICMJE Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: An Assessment of Acute Toxicity and Long Term Neurocognitive, Neuroendocrine and Ototoxicity Outcomes
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Tumor
  • Medulloblastoma
  • Pineoblastoma
Intervention  ICMJE Radiation: proton beam radiation
Given once a day, 5 days a week (Monday-Friday)
Study Arms  ICMJE Experimental: Proton Beam Radiation
Proton Beam Radiation
Intervention: Radiation: proton beam radiation
Publications * Vatner RE, Niemierko A, Misra M, Weyman EA, Goebel CP, Ebb DH, Jones RM, Huang MS, Mahajan A, Grosshans DR, Paulino AC, Stanley T, MacDonald SM, Tarbell NJ, Yock TI. Endocrine Deficiency As a Function of Radiation Dose to the Hypothalamus and Pituitary in Pediatric and Young Adult Patients With Brain Tumors. J Clin Oncol. 2018 Oct 1;36(28):2854-2862. doi: 10.1200/JCO.2018.78.1492. Epub 2018 Aug 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 3, 2010)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01063114
Other Study ID Numbers  ICMJE 09-361
P01CA021239 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Torunn Yock, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Torunn I Yock, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2020

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