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

  • STATUS
    Recruiting
  • days left to enroll
    85
  • participants needed
    70
  • sponsor
    Emory University
Updated on 4 June 2022
pituitary
meningioma
tumor cells

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.

Details
Condition Grade I Meningioma, Grade II Meningioma, Grade III Meningioma, Intracranial Neoplasm, Nerve Sheath Neoplasm, Pituitary Gland Adenoma, Schwannoma
Treatment questionnaire administration, quality-of-life assessment, hypofractionated radiation therapy, Proton Beam Radiation Therapy, photon beam radiation therapy
Clinical Study IdentifierNCT04278118
SponsorEmory University
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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