RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-02-18
Study Completion:2025-10-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04278118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Recommended to receive proton or photon fractionated radiation therapy
  3. * Signed informed consent
  1. * 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.
  2. * 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)
  3. * Prior radiation therapy that would overlap with current target volume
  4. * Inability to undergo magnetic resonance imaging (MRI)

Contacts and Locations

Principal Investigator

Bree R Eaton
PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute

Study Locations (Sites)

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Bree R Eaton, PRINCIPAL_INVESTIGATOR, Emory University Hospital/Winship Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-18
Study Completion Date2025-10-23

Study Record Updates

Study Start Date2020-02-18
Study Completion Date2025-10-23

Terms related to this study

Additional Relevant MeSH Terms

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