Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

Brain Tumor Clinical Trial

Official title:

Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma: An Assessment of Acute Toxicity and Long Term Neurocognitive, Neuroendocrine and Ototoxicity Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01063114
• Other study ID #: 09-361
• Secondary ID: P01CA021239
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2010
• Est. completion date: November 2025

Study information

• Verified date: January 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Tumor
• Medulloblastoma
• Pinealoma
• Pineoblastoma

Intervention

Radiation:
• proton beam radiation
Given once a day, 5 days a week (Monday-Friday)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	M.D. Anderson Cancer Center, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ototoxicity	Incidence and severity of ototoxicity at three years following the completion of radiation therapy.	3 years
Primary	Endocrine dysfunction	Incidence and severity of endocrine dysfunction at three years following completion of proton radiation therapy.	3 years
Primary	Neurocognitive Effects	Incidence and severity of neurocognitive sequelae overall and in subgroups based on whether or not methotrexate was used as part of the treatment regimen	3 years
Secondary	Progression Free Survival	3-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment.	3 years
Secondary	Treatment efficiency	Speed of treating patients requiring cranial spinal irradiation and improve the safety of treating patients under anesthesia	2 years
Secondary	Acute toxicity	Frequency and severity of acute side effects from CSI using proton beam therapy, including nausea, esophagitis, and weight loss.	2 years