Proton Radiation for Treating Benign or Indolent Brain Tumors
Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy
This study is testing whether Proton Radiation therapy can effectively treat adults with benign or slow-growing brain tumors and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03286335 on ClinicalTrials.gov |
What this trial studies
This research focuses on the effectiveness of Proton Radiation therapy in treating adults with benign or indolent brain tumors. The study aims to evaluate the tumor's response to the treatment over a period of up to five years, while also assessing the impact on patients' quality of life and any side effects experienced. Participants will receive Proton Radiation, which is not yet FDA-approved for this specific condition but has been approved for other uses. The study includes various types of brain tumors that require irradiation, allowing for a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven benign or malignant brain tumors that require irradiation.
Not a fit: Patients with aggressive brain tumors that do not fall under the benign or indolent category may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients with benign or indolent brain tumors, potentially improving their quality of life.
How similar studies have performed: While Proton Radiation has been used successfully for other conditions, this specific application for benign or indolent brain tumors is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Helen A Shih, MD — Massachusetts General Hospital
- Study coordinator: Tarin Grillo
- Email: TGRILLO@mgh.harvard.edu
- Phone: 617-724-3661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.