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

Brief Title

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

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

local tumor control

Secondary Outcome

 Neurocognitive effects

Condition

Grade I Meningioma

Intervention

Hypofractionated Radiation Therapy

Study Arms / Comparison Groups

 Cohort I (hypofractionated radiation therapy)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

70

Start Date

February 18, 2020

Completion Date

April 30, 2023

Primary Completion Date

April 30, 2023

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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Bree R Eaton, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04278118

Organization ID

IRB00114529

Secondary IDs

NCI-2019-06446

Responsible Party

Principal Investigator

Study Sponsor

Emory University

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Bree R Eaton, Principal Investigator, Emory University Hospital/Winship Cancer Institute


Verification Date

April 2020