Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03286335 : Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03286335      |      Link to official Clinicaltrials.gov listing
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