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

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ClinicalTrials.gov Identifier: NCT04278118
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bree Eaton, Emory University

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.

Condition or disease Intervention/treatment Phase
Grade I Meningioma Grade II Meningioma Grade III Meningioma Intracranial Neoplasm Nerve Sheath Neoplasm Pituitary Gland Adenoma Schwannoma Radiation: Hypofractionated Radiation Therapy Radiation: Photon Beam Radiation Therapy Radiation: Proton Beam Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HiPPI: A Phase 2 Trial of Hypofractionated Pencil Beam Scanning Proton Therapy for Benign Intracranial Tumors
Actual Study Start Date : February 18, 2020
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023


Arm Intervention/treatment
Experimental: 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.
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated proton or photon radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation

Radiation: Photon Beam Radiation Therapy
Undergo hypofractionated proton or photon radiation therapy

Radiation: Proton Beam Radiation Therapy
Undergo hypofractionated proton or photon radiation therapy
Other Names:
  • PBRT
  • Proton Radiation Therapy
  • Radiation, Proton Beam

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: 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.
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated proton or photon radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation

Radiation: Photon Beam Radiation Therapy
Undergo hypofractionated proton or photon radiation therapy

Radiation: Proton Beam Radiation Therapy
Undergo hypofractionated proton or photon radiation therapy
Other Names:
  • PBRT
  • Proton Radiation Therapy
  • Radiation, Proton Beam

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. local tumor control [ Time Frame: Up to 3 years since enrollment ]
    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.

  2. Incidence of adverse events [ Time Frame: up to 3 years ]
    Will be assessed and graded according to Common Terminology Criteria for Adverse Events version 5.0


Secondary Outcome Measures :
  1. Neurocognitive effects [ Time Frame: Up to 3 years ]
    Will be summarized by summary statistics.

  2. Health related quality of life [ Time Frame: Up to 3 years ]
    Will be summarized by summary statistics.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278118


Locations
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United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Bree R. Eaton    404-251-2690    brupper@emory.edu   
Principal Investigator: Bree R. Eaton         
Sponsors and Collaborators
Emory University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bree R Eaton Emory University Hospital/Winship Cancer Institute
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Responsible Party: Bree Eaton, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04278118    
Other Study ID Numbers: IRB00114529
NCI-2019-06446 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RAD4811-19 ( Other Identifier: Emory University Hospital/Winship Cancer Institute )
P30CA138292 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms
Brain Neoplasms
Nerve Sheath Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Brain Diseases
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Peripheral Nervous System Neoplasms
Adenoma
Meningioma
Neurilemmoma
Central Nervous System Diseases
Nervous System Diseases
Neuroma
Peripheral Nervous System Diseases
Neuromuscular Diseases