Clinical trial NCT03286335: Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy
Official title: Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Tumor
Keywords: Brain Tumor
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: The main purpose of this study is to see how well the tumor is responding to the Proton Radiation up to 5 years after the participant receive it. The investigators are also looking for how this type of radiation affects the quality of life as well as any type of side effect the participant may have after the radiation is administered.

The FDA (the U.S. Food and Drug Administration) has not approved Proton Radiation for this specific disease but it has been approved for other uses.

Eligibility 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

Primary outcomes:
measure: Duration of Local Control
timeFrame: 2 years
Secondary outcomes:
measure: Quality of Life Assessment EORTC-QLQ-C30
timeFrame: 2 years
measure: Quality of Life Assessment EORTC-QLQ-BN20
timeFrame: 2 Years
measure: Quality of Life Assessment HADS
timeFrame: 2 Years
measure: Vision Loss
timeFrame: 2 years
measure: Ototoxicity
timeFrame: 2 years
measure: Neuroendocrine dysfunction
timeFrame: 2 years
measure: Neurocognitive effects
timeFrame: 2 years
measure: Alopecia
timeFrame: 2 years
measure: CD4 count
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Helen A Shih, MD
role: PRINCIPAL_INVESTIGATOR
References: