Recruiting

Hypofractionated Proton Therapy

Sponsor:

Emory University

Code:

NCT04278118

Conditions

Grade I Meningioma

Grade II Meningioma

Grade III Meningioma

Intracranial Neoplasm

Nerve Sheath Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypofractionated Radiation Therapy

Photon Beam Radiation Therapy

Proton Beam Radiation Therapy

Quality-of-Life Assessment

Questionnaire Administration

Study Details

Brief 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.

Conditions

Grade I Meningioma

Grade II Meningioma

Grade III Meningioma

Intracranial Neoplasm

Nerve Sheath Neoplasm

Study ID

NCT04278118

Start date

Feb 18, 2020

Status verified date

Jan, 2026

Completion date

Dec 1, 2031

Anticipated

Primary completion date

Dec 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort I (hypofractionated radiation therapy)

Patients with benign and radiographically diagnosed intracranial tumors undergo hypofractionated proton or photon radiation therapy daily, Monday-Friday over 17 fractions for 3.5-4 weeks in the absence of disease progression or unacceptable toxicity.

experimental: Cohort II (hypofractionated radiation therapy)

Patients with pathologically confirmed World Health Organization (WHO) grade 2-3 meningiomas undergo hypofractionated proton or photon radiation therapy daily, Monday-Friday over 20 fractions for 3.5-4 weeks in the absence of disease progression or unacceptable toxicity.

Interventions

Hypofractionated Radiation Therapy

Undergo hypofractionated proton or photon radiation therapy

Photon Beam Radiation Therapy

Undergo hypofractionated proton or photon radiation therapy

Proton Beam Radiation Therapy

Undergo hypofractionated proton or photon radiation therapy

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • local tumor control [ Time Frame: Up to 3 years since enrollment ]
  • Incidence of adverse events [ Time Frame: up to 3 years ]

Central Contacts and Locations

Locations

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Bree R. Eaton

404-251-2690brupper@emory.edu

Principal Investigator:

Bree R. Eaton

More Information

Sponsor

Emory University

Last update posted

Feb 17, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-02-17.