Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy

NCT03286335 | Recruiting DMC FDA Device

• 1 other identifier: 17-250
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying Proton Radiation as a possible treatment for brain tumor. The radiation involved in this study is:

• Proton Radiation

Conditions

Brain Tumor

Keywords

Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Duration of Local Control

  The duration of local control will be measured from the start date of protocol radiation until the date of progressive disease. Local control is defined as the lack of tumor growth as determined by a brain MRI (magnetic resonance imaging). This will include tumors that appear unchanged in size as compared to the baseline pre-radiation scan and also tumors that appear slightly reduced in size as may occur in response to radiation therapy. Inflammation secondary to radiation therapy can radiographically mimic subtle disease progression and may need to be confirmed with serial imaging. Progression is defined as an increase in the size of the tumor, a significant increase in T2/FLAIR non-enhancing lesion on sable or increasing doses of corticosteroids compared to baseline, the appearance of any new lesion, clear clinical deterioration not attributable to any other cause apart from the tumor, or failure to return for evaluation due to death or deteriorating condition.

  2 years

Secondary Outcomes (9)

• Quality of Life Assessment EORTC-QLQ-C30

  2 years

• Quality of Life Assessment EORTC-QLQ-BN20

  2 Years

• Quality of Life Assessment HADS

  2 Years

• Vision Loss

  2 years

• Ototoxicity

  2 years

Study Arms (1)

Proton Radiation

EXPERIMENTAL

* Radiation therapy will be delivered typically five (5) days per week on weekdays * Proton Radiation dose be determine by histology

Radiation: Proton Radiation

Interventions

Proton Radiation RADIATION

Radiation treatment

Proton Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-proven benign or malignant brain tumor requiring tumor bed or tumor irradiation. This may include, but is not limited to, low-grade or favorable high-grade glioma, pituitary adenoma, vestibular schwannoma (acoustic neuroma), and meningioma as the most common diagnoses. Other tumor types that require irradiation and are deemed appropriate for proton radiation therapy are also eligible. Patients with a presumed diagnosis based on imaging and clinical characteristics will be permitted on this trial without pathological diagnostic confirmation if it is within standard of care to offer radiation therapy without a biopsy.
• Participants must otherwise be indicated for proton radiation therapy
• Age 18 years or older
• Karnofsky performance status ≥ 60 (see Appendix A)
• Participants may have had any extent of prior surgery and/or chemotherapy.
• Must be able to speak and comprehend English
• Ability to understand and willingness to sign a written informed consent document
• The effects of proton radiation therapy on the developing human fetus are known to be teratogenic. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and 4 months after completion of proton therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study treatment, and 4 months after completion of proton therapy.
• Life expectancy greater than or equal to 6 months.

You may not qualify if:

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or lactating women are excluded from this study because radiation is known to have teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiation therapy, breastfeeding should be discontinued if the mother is treated with radiation therapy.
• Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

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

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Helen A Shih, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarin Grillo

CONTACT

617-724-3661; TGRILLO@mgh.harvard.edu

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: Shih, Helen A, MD

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 18, 2017
• Study Start: September 26, 2018
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)