Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

Not Applicable

Completed

• Conditions: Brain Tumor; Medulloblastoma; Pineoblastoma

• Registration Number: NCT01063114
• Lead Sponsor: Massachusetts General Hospital

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 Timeline

• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-05
• Study Start: 2010-04-08
• Primary Completion: 2021-11
• Study Completion: 2021-11-01
• Results First Submitted: 2025-04-01
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Results First Posted: 2025-08-13
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cumulative Incidence of Ototoxicity	3- and 5- years post radiation treatment	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)
Neurocognitive Effects	Baseline and Follow-up (median of 6 years)	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.
Endocrine Dysfunction	3- and 5- years post radiation treatment	Cumulative incidence (estimated percentage participants) that developed endocrine dysfunction at 3- and 5-years following completion of proton radiation therapy.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	3- and 5-years post radiation treatment	3- and 5-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment.
Treatment Efficiency	2 years	To modify the speed of treating patients requiring cranial spinal irradiation (CSI) and improve the safety of treating patients under anesthesia
Percentage of Participants Who Experienced an Acute Toxicity by Grade	3 months after radiation therapy	All patients shall be assessed for acute toxicity on a weekly basis during craniospinal irradiation (CSI). Percentage of participants who experienced an acute toxicity by grade. Acute toxicities are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Toxicities are graded on a scale of 1 to 5. A higher grade indicates a worse outcome with 1 being mild, 4 being life-threatening, and 5 being death.

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States