Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

NCT01063114 | Completed Results DMC

• 2 other identifiers: 09-361P01CA021239
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Brain Tumor; Medulloblastoma; Pineoblastoma

Keywords

proton beam radiation

Outcome Measures

Primary Outcomes (3)

• Cumulative Incidence of Ototoxicity

  Cumulative incidence (estimated percentage participants) who experienced ototoxicity defined as either grade 3 or 4 hearing loss in either ear after the completion of radiation therapy in the overall participant population. Cumulative incidence and 95% confidence intervals are shown at 3- and 5-years post RT (radiation treatment)

  3- and 5- years post radiation treatment

• Endocrine Dysfunction

  Cumulative incidence (estimated percentage participants) that developed endocrine dysfunction at 3- and 5-years following completion of proton radiation therapy.

  3- and 5- years post radiation treatment

• Neurocognitive Effects

  Difference in Full-Scale Intelligence Quotient (FSIQ) between baseline and latest follow-up neurocognitive test. Tests used include WISC (Wechsler Intelligence Scale for Children) IV, WISC V, WAIS (Wechsler Adult Intelligence Scale) III, WAIS IV. The test measures the FSIQ of children through four indices; the Verbal Comprehension Index (VCI), Perceptual Reasoning Index (PRI), working memory test, and a processing speed test. FSIQ and the four indices are all assessed on a bell curve scale with an average score of 100 and standard deviation of 15. Higher scores represent higher intelligence and lower scores represent reduced intelligence.

  Baseline and Follow-up (median of 6 years)

Secondary Outcomes (3)

• Progression Free Survival

  3- and 5-years post radiation treatment

• Treatment Efficiency

  2 years

• Percentage of Participants Who Experienced an Acute Toxicity by Grade

  3 months after radiation therapy

Study Arms (1)

Proton Beam Radiation

EXPERIMENTAL

Proton Beam Radiation

Radiation: proton beam radiation

Interventions

proton beam radiation RADIATION

Given once a day, 5 days a week (Monday-Friday)

Proton Beam Radiation

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• M.D. Anderson Cancer Center: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 30118397 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Medulloblastoma; Pinealoma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Torunn Yock, MD
• Organization: Massachusetts General, Hospital

tyock@mgh.harvard.edu

6177262000

Study Officials

• Torunn I Yock, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Radiation Oncology

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 5, 2010
• Study Start: April 8, 2010
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-08

Locations

US (2)