Clinical trial NCT04278118: Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study
Official title: HiPPI: A Phase 2 Trial of Hypofractionated Pencil Beam Scanning Proton Therapy for Benign Intracranial Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Grade I Meningioma
Grade II Meningioma
Grade III Meningioma
Intracranial Neoplasm
Nerve Sheath Neoplasm
Pituitary Gland Adenoma
Schwannoma
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-02-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: PRIMARY OBJECTIVE:

I. To report 3 year local tumor control of moderately hypofractionated proton or photon therapy for benign intracranial tumors.

SECONDARY OBJECTIVES:

I. To demonstrate feasibility of moderate hypofractionation pencil beam scanning proton therapy for intracranial tumors.

II. To report physician reported acute and late toxicity of moderate hypofractionation pencil beam scanning proton therapy for intracranial tumors according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

III. To report neurocognitive effects, health related quality of life, and patient reported toxicity for moderate hypofractionation pencil beam scanning proton therapy for intracranial tumors.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I: 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.

COHORT II: 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.

After completion of study treatment, patients are followed up periodically.

Eligibility criteria: 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)

Primary outcomes:
measure: local tumor control
timeFrame: Up to 3 years since enrollment
measure: Incidence of adverse events
timeFrame: up to 3 years
Secondary outcomes:
measure: Neurocognitive effects
timeFrame: Up to 3 years
measure: Health related quality of life
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Bree R Eaton
role: PRINCIPAL_INVESTIGATOR
References: