Hypofractionated proton therapy for benign brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of hypofractionated proton or photon radiation therapy in treating patients with benign intracranial tumors, including various grades of meningiomas. The approach involves delivering higher doses of radiation over a shorter treatment period, which may enhance tumor cell death while minimizing delayed side effects. Patients are assigned to cohorts based on their tumor type and receive treatment daily for several weeks, followed by periodic follow-ups to assess outcomes and side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathologically or radiographically diagnosed benign intracranial or nerve sheath tumor, including meningiomas, pituitary adenomas, schwannomas. World Health Organization (WHO) grade 2-3 meningiomas are also allowed
* Recommended to receive proton or photon fractionated radiation therapy
* Signed informed consent

Exclusion Criteria:

* Pregnant females are excluded. Female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy. FCBP must agree to use adequate contraception (at least one highly effective method and one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of study. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.

  * A female of childbearing potential (FCBP) is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (if age \>= 55 years); if the female subject is \< 55 years and she has been naturally postmenopausal for \>= 1 year her reproductive status has to be verified by additional laboratory (lab) tests (\< 20 estradiol OR estradiol \< 40 with follicle stimulating hormone \[FSH\] \> 40 in women not on estrogen replacement therapy)
* Prior radiation therapy that would overlap with current target volume
* Inability to undergo magnetic resonance imaging (MRI)

Where it's running

• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Bree R Eaton — Emory University Hospital/Winship Cancer Institute

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.