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

NCT ID: NCT04278118

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-18

Study Completion Date

2031-12-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Hypofractionated Radiation Therapy

Intervention Type RADIATION

Undergo hypofractionated proton or photon radiation therapy

Photon Beam Radiation Therapy

Intervention Type RADIATION

Undergo hypofractionated proton or photon radiation therapy

Proton Beam Radiation Therapy

Intervention Type RADIATION

Undergo hypofractionated proton or photon radiation therapy

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Hypofractionated Radiation Therapy

Intervention Type RADIATION

Undergo hypofractionated proton or photon radiation therapy

Photon Beam Radiation Therapy

Intervention Type RADIATION

Undergo hypofractionated proton or photon radiation therapy

Proton Beam Radiation Therapy

Intervention Type RADIATION

Undergo hypofractionated proton or photon radiation therapy

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Hypofractionated Radiation Therapy

Undergo hypofractionated proton or photon radiation therapy

Intervention Type RADIATION

Photon Beam Radiation Therapy

Undergo hypofractionated proton or photon radiation therapy

Intervention Type RADIATION

Proton Beam Radiation Therapy

Undergo hypofractionated proton or photon radiation therapy

Intervention Type RADIATION

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Hypofractionated Radiotherapy hypofractionation PBRT Proton Radiation Therapy Radiation, Proton Beam Quality of Life Assessment

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Bree Eaton

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bree R Eaton

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

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Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Bree R. Eaton

Role: primary

Other Identifiers

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NCI-2019-06446

Identifier Type: REGISTRY

Identifier Source: secondary_id

RAD4811-19

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00114529

Identifier Type: -

Identifier Source: org_study_id