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

Primary Purpose

Grade I Meningioma, Grade II Meningioma, Grade III Meningioma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hypofractionated Radiation Therapy

Photon Beam Radiation Therapy

Proton Beam Radiation Therapy

Quality-of-Life Assessment

Questionnaire Administration

About this trial

This is an interventional treatment trial for Grade I Meningioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Emory University Hospital/Winship Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort I (hypofractionated radiation therapy)

Cohort II (hypofractionated radiation therapy)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Incidence of adverse events

Will be assessed and graded according to Common Terminology Criteria for Adverse Events version 5.0

Secondary Outcome Measures

Neurocognitive effects

Will be summarized by summary statistics.

Health related quality of life

Will be summarized by summary statistics.

Full Information

NCT ID

NCT04278118

First Posted

February 7, 2020

Last Updated

June 8, 2023

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04278118

Brief Title

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

Acronym

HiPPI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 18, 2020 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Grade I Meningioma, Grade II Meningioma, Grade III Meningioma, Intracranial Neoplasm, Nerve Sheath Neoplasm, Pituitary Gland Adenoma, Schwannoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort I (hypofractionated radiation therapy)

Arm Type

Experimental

Arm Description

Arm Title

Cohort II (hypofractionated radiation therapy)

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Hypofractionated Radiation Therapy

Other Intervention Name(s)

Hypofractionated Radiotherapy, hypofractionation

Intervention Description

Undergo hypofractionated proton or photon radiation therapy

Intervention Type

Radiation

Intervention Name(s)

Photon Beam Radiation Therapy

Intervention Description

Undergo hypofractionated proton or photon radiation therapy

Intervention Type

Radiation

Intervention Name(s)

Proton Beam Radiation Therapy

Other Intervention Name(s)

PBRT, Proton Radiation Therapy, Radiation, Proton Beam

Intervention Description

Undergo hypofractionated proton or photon radiation therapy

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

local tumor control

Description

Time Frame

Up to 3 years since enrollment

Title

Incidence of adverse events

Description

Will be assessed and graded according to Common Terminology Criteria for Adverse Events version 5.0

Time Frame

up to 3 years

Secondary Outcome Measure Information:

Title

Neurocognitive effects

Description

Will be summarized by summary statistics.

Time Frame

Up to 3 years

Title

Health related quality of life

Description

Will be summarized by summary statistics.

Time Frame

Up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bree R Eaton

Organizational Affiliation

Emory University Hospital/Winship Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Hospital/Winship Cancer Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bree R. Eaton

Phone

404-251-2690

brupper@emory.edu

First Name & Middle Initial & Last Name & Degree

Bree R. Eaton

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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