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

Intracranial Neoplasm Clinical Trial

— HiPPI  

Official title:

HiPPI: A Phase 2 Trial of Hypofractionated Pencil Beam Scanning Proton Therapy for Benign Intracranial Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04278118
• Other study ID #: IRB00114529
• Secondary ID: NCI-2019-06446RA
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2020
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenoma
• Brain Neoplasms
• Grade I Meningioma
• Grade II Meningioma
• Grade III Meningioma
• Intracranial Neoplasm
• Meningioma
• Neoplasms
• Nerve Sheath Neoplasm
• Nerve Sheath Neoplasms
• Neurilemmoma
• Pituitary Gland Adenoma
• Schwannoma

Intervention

Radiation:
• 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

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local tumor control	Will assess local tumor control rate. Local tumor control is defined as freedom from progressive disease (PD). Will be calculated as the proportion of patients who did not experience PD within 3-year follow up with 95% binomial proportion confidence interval for the entire population and each cohort independently. The same calculation will be repeated for the entire study population and each cohort separately. Kaplan-Meier method will be used to estimate the local control rates for the entire population and each cohort independently.	Up to 3 years since enrollment
Primary	Incidence of adverse events	Will be assessed and graded according to Common Terminology Criteria for Adverse Events version 5.0	up to 3 years
Secondary	Neurocognitive effects	Will be summarized by summary statistics.	Up to 3 years
Secondary	Health related quality of life	Will be summarized by summary statistics.	Up to 3 years