Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study
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
| Condition(s) | Grade I Meningioma, Grade II Meningioma, Grade III Meningioma, Intracranial Neoplasm, Nerve Sheath Neoplasm, Pituitary Gland Adenoma, Schwannoma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 part |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Emory University |
| Locations | Atlanta, Georgia, United States |
| Start date | 2020-02-18 |
| NCT ID | NCT04278118 |
| Official listing | https://clinicaltrials.gov/study/NCT04278118 |