Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT04278118
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2020-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D010911', 'term': 'Pituitary Neoplasms'}, {'id': 'D009442', 'term': 'Neurilemmoma'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009463', 'term': 'Neuroma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069473', 'term': 'Radiation Dose Hypofractionation'}, {'id': 'D061766', 'term': 'Proton Therapy'}, {'id': 'D011522', 'term': 'Protons'}], 'ancestors': [{'id': 'D019583', 'term': 'Dose Fractionation, Radiation'}, {'id': 'D011879', 'term': 'Radiotherapy Dosage'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}, {'id': 'D002414', 'term': 'Cations, Monovalent'}, {'id': 'D002412', 'term': 'Cations'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D006859', 'term': 'Hydrogen'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D000071940', 'term': 'Nucleons'}, {'id': 'D004601', 'term': 'Elementary Particles'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2031-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'local tumor control', 'timeFrame': 'Up to 3 years since enrollment', 'description': '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.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'up to 3 years', 'description': 'Will be assessed and graded according to Common Terminology Criteria for Adverse Events version 5.0'}], 'secondaryOutcomes': [{'measure': 'Neurocognitive effects', 'timeFrame': 'Up to 3 years', 'description': 'Will be summarized by summary statistics.'}, {'measure': 'Health related quality of life', 'timeFrame': 'Up to 3 years', 'description': 'Will be summarized by summary statistics.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Grade I Meningioma', 'Grade II Meningioma', 'Grade III Meningioma', 'Intracranial Neoplasm', 'Nerve Sheath Neoplasm', 'Pituitary Gland Adenoma', 'Schwannoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To report 3 year local tumor control of moderately hypofractionated proton or photon therapy for benign intracranial tumors.\n\nSECONDARY OBJECTIVES:\n\nI. To demonstrate feasibility of moderate hypofractionation pencil beam scanning proton therapy for intracranial tumors.\n\nII. 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.\n\nIII. To report neurocognitive effects, health related quality of life, and patient reported toxicity for moderate hypofractionation pencil beam scanning proton therapy for intracranial tumors.\n\nOUTLINE: Patients are assigned to 1 of 2 cohorts.\n\nCOHORT 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.\n\nCOHORT 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.\n\nAfter completion of study treatment, patients are followed up periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Recommended to receive proton or photon fractionated radiation therapy\n* Signed informed consent\n\nExclusion Criteria:\n\n* 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.\n\n * 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)\n* Prior radiation therapy that would overlap with current target volume\n* Inability to undergo magnetic resonance imaging (MRI)'}, 'identificationModule': {'nctId': 'NCT04278118', 'acronym': 'HiPPI', 'briefTitle': 'Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'HiPPI: A Phase 2 Trial of Hypofractionated Pencil Beam Scanning Proton Therapy for Benign Intracranial Tumors', 'orgStudyIdInfo': {'id': 'IRB00114529'}, 'secondaryIdInfos': [{'id': 'NCI-2019-06446', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'RAD4811-19', 'type': 'OTHER', 'domain': 'Emory University Hospital/Winship Cancer Institute'}, {'id': 'P30CA138292', 'link': 'https://reporter.nih.gov/quickSearch/P30CA138292', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '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.', 'interventionNames': ['Radiation: Hypofractionated Radiation Therapy', 'Radiation: Photon Beam Radiation Therapy', 'Radiation: Proton Beam Radiation Therapy', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort II (hypofractionated radiation therapy)', 'description': '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.', 'interventionNames': ['Radiation: Hypofractionated Radiation Therapy', 'Radiation: Photon Beam Radiation Therapy', 'Radiation: Proton Beam Radiation Therapy', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Hypofractionated Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Hypofractionated Radiotherapy', 'hypofractionation'], 'description': 'Undergo hypofractionated proton or photon radiation therapy', 'armGroupLabels': ['Cohort I (hypofractionated radiation therapy)', 'Cohort II (hypofractionated radiation therapy)']}, {'name': 'Photon Beam Radiation Therapy', 'type': 'RADIATION', 'description': 'Undergo hypofractionated proton or photon radiation therapy', 'armGroupLabels': ['Cohort I (hypofractionated radiation therapy)', 'Cohort II (hypofractionated radiation therapy)']}, {'name': 'Proton Beam Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['PBRT', 'Proton Radiation Therapy', 'Radiation, Proton Beam'], 'description': 'Undergo hypofractionated proton or photon radiation therapy', 'armGroupLabels': ['Cohort I (hypofractionated radiation therapy)', 'Cohort II (hypofractionated radiation therapy)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Cohort I (hypofractionated radiation therapy)', 'Cohort II (hypofractionated radiation therapy)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Cohort I (hypofractionated radiation therapy)', 'Cohort II (hypofractionated radiation therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bree R. Eaton', 'role': 'CONTACT', 'email': 'brupper@emory.edu', 'phone': '404-251-2690'}, {'name': 'Bree R. Eaton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University Hospital/Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Bree R Eaton', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University Hospital/Winship Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bree Eaton', 'investigatorAffiliation': 'Emory University'}}}}