Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT01878266
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2013-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080443', 'term': 'Diffuse Intrinsic Pontine Glioma'}], 'ancestors': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D020295', 'term': 'Brain Stem Neoplasms'}, {'id': 'D015192', 'term': 'Infratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-03', 'studyFirstSubmitDate': '2013-06-09', 'studyFirstSubmitQcDate': '2013-06-12', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median overall-free survival', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diffuse Intrinsic Pontine Glioma (DIPG)', 'Hypofractionated Radiotherapy', 'Radiotherapy', 'Median survival'], 'conditions': ['Pediatric Brain Stem Glioma']}, 'descriptionModule': {'briefSummary': "This Trial offers a reduction in patient burden, which is especially preferable in children with a poor compliance and poor performance status. This prospective randomized trial was extension to the previous controlled prospective study performed in Children's Cancer Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this work is to demonstrate noninferiority of the hypofractionated regimens relative to the conventional regimen in a controlled randomized clinical study.", 'detailedDescription': 'In this study will add a third arm in which we will increase in the total dose to 4500 cGy in 15 fractions in 3 weeks may lead to improvement in Over-all survival or Progression-Free Survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed patients with a diffuse intrinsic brainstem glioma\n2. Aged 2-18years,\n3. Have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs.\n4. No performance criteria were required for entry onto the study.\n\nExclusion Criteria:\n\n* Children were not eligible if they had received any prior therapy other than steroids Treatment'}, 'identificationModule': {'nctId': 'NCT01878266', 'briefTitle': 'Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Cancer Hospital Egypt 57357"}, 'officialTitle': 'Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma', 'orgStudyIdInfo': {'id': 'CCHE-BT002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypofractionated Arm (1)', 'description': 'A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week , by conformal radiotherapy sparing of the supratentorial brain. The planning target volume included the tumor as defined by the T2-weighted MRI images with a margin of 1.5-2.0 cm. Margins were adjusted for bony structures and tentorium. With exception of steroids, no neoadjuvant, concomitant, or adjuvant systemic treatment was allowed', 'interventionNames': ['Radiation: Hypofractionated Arm (1)']}, {'type': 'EXPERIMENTAL', 'label': 'Hypofractionated Arm (2)', 'description': 'The same planning and treatment procedures will be performed. The total dose will be 4500 cGy in 15 fractions in 3 weeks; giving 300 cGy per fraction.', 'interventionNames': ['Radiation: Hypofractionated Arm (2)']}, {'type': 'OTHER', 'label': 'Conventional Arm (3)', 'description': 'The same planning and treatment procedures will be performed with 54.0 Gy in 30 fractions giving 1.8 Gy per fraction.', 'interventionNames': ['Radiation: Conventional Arm (3)']}], 'interventions': [{'name': 'Hypofractionated Arm (1)', 'type': 'RADIATION', 'description': 'A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week', 'armGroupLabels': ['Hypofractionated Arm (1)']}, {'name': 'Hypofractionated Arm (2)', 'type': 'RADIATION', 'description': 'The total dose to 4500 cGy in 15 fractions in 3 weeks', 'armGroupLabels': ['Hypofractionated Arm (2)']}, {'name': 'Conventional Arm (3)', 'type': 'RADIATION', 'description': 'A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm', 'armGroupLabels': ['Conventional Arm (3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11441', 'city': 'Cairo', 'country': 'Egypt', 'facility': "Children's Cancer Hospital Egypt 57357", 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Cancer Hospital Egypt 57357", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}