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Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

Primary Purpose

Brain Tumor, Medulloblastoma, Pineoblastoma

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

proton beam radiation

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring proton beam radiation

Eligibility Criteria

3 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital
MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton Beam Radiation

Arm Description

Proton Beam Radiation

Outcomes

Primary Outcome Measures

Ototoxicity

Incidence and severity of ototoxicity at three years following the completion of radiation therapy.

Endocrine dysfunction

Incidence and severity of endocrine dysfunction at three years following completion of proton radiation therapy.

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

Secondary Outcome Measures

Progression Free Survival

3-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment.

Treatment efficiency

Speed of treating patients requiring cranial spinal irradiation and improve the safety of treating patients under anesthesia

Acute toxicity

Frequency and severity of acute side effects from CSI using proton beam therapy, including nausea, esophagitis, and weight loss.

Full Information

NCT ID

NCT01063114

First Posted

February 3, 2010

Last Updated

January 5, 2023

Sponsor

Massachusetts General Hospital

Collaborators

M.D. Anderson Cancer Center, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01063114

Brief Title

Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 2010 (Actual)

Primary Completion Date

November 2025 (Anticipated)

Study Completion Date

November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

M.D. Anderson Cancer Center, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Tumor, Medulloblastoma, Pineoblastoma

Keywords

proton beam radiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Proton Beam Radiation

Arm Type

Experimental

Arm Description

Proton Beam Radiation

Intervention Type

Radiation

Intervention Name(s)

proton beam radiation

Intervention Description

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

Primary Outcome Measure Information:

Title

Ototoxicity

Description

Incidence and severity of ototoxicity at three years following the completion of radiation therapy.

Time Frame

3 years

Title

Endocrine dysfunction

Description

Incidence and severity of endocrine dysfunction at three years following completion of proton radiation therapy.

Time Frame

3 years

Title

Neurocognitive Effects

Description

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

Secondary Outcome Measure Information:

Title

Progression Free Survival

Description

3-year progression free survival rate of pediatric medulloblastoma and pineoblastoma patients treated with proton CSI treatment.

Time Frame

3 years

Title

Treatment efficiency

Description

Speed of treating patients requiring cranial spinal irradiation and improve the safety of treating patients under anesthesia

Time Frame

2 years

Title

Acute toxicity

Description

Frequency and severity of acute side effects from CSI using proton beam therapy, including nausea, esophagitis, and weight loss.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Torunn I Yock, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30118397

Citation

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.

Results Reference

derived

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Proton Beam Radiotherapy for Medulloblastoma and Pineoblastoma

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