Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

This phase II trial studies how well hypofractionated proton or photon radiation therapy works in treating patients with brain tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells. A shorter duration of radiation treatment may avoid some of the delayed side effects of radiation while providing a more convenient treatment and reducing costs.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Hypofractionated Radiation Therapy
  • Photon Beam Radiation Therapy
  • Proton Beam Radiation Therapy
  • Quality-of-Life Assessment
  • Questionnaire Administration

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator