Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-02 @ 11:33 AM
Study NCT ID:
NCT06835803
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will use a hybrid design that also leverages an external control dataset in order to adjust the randomization ratio in favor of the experimental arm.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Overall survival from time of enrollment through study completion, an average of 1 year', 'description': 'through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Time of enrollment to time of progressionfrom time of enrollment through study completion, an average of 6 months'}, {'measure': 'Treatment-related toxicity', 'timeFrame': 'Time of enrollment to end of treatment (upto 6 months after completion of radiation therapy)', 'description': 'Per CTCAE 5.0'}, {'measure': 'Health-related quality of life', 'timeFrame': 'From time of enrollment upto 6 months later', 'description': 'This will be measured by EORTC QLQ-C30 and QLQ-BN20 tools. Evaluation for changes in health-related quality of life by these instruments upto 6 months after radiation therapy.'}, {'measure': 'Mood symptoms', 'timeFrame': 'From time of enrollment upto 6 months later', 'description': 'Measured by the Patient Health Questionnaire (PHQ-4). Evaluation of changes to PHQ-4 scores over time upto 6 months after radiation treatment.'}, {'measure': 'Practical Geriatric Assessment', 'timeFrame': 'From time of enrollment upto 6 months later'}, {'measure': 'Performance status', 'timeFrame': 'From time of enrollment upto 6 months later', 'description': 'Measured by Karnofsky Performance Status. Evaluation of changes of performance status over time upto 6 months after radiation treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glioblastoma', 'elderly glioblastoma', 'hypofractionation'], 'conditions': ['Glioblastoma (GBM)']}, 'descriptionModule': {'briefSummary': 'Glioblastoma (GBM) is an aggressive malignancy of the central nervous system. Older adults with GBM have a unique constellation of medical, psychosocial, and supportive care needs. To address these challenges, prior work has evaluated the feasibility of hypofractionation, a treatment approach delivering fewer, larger radiation dosages over a shorter time period. Common hypofractionated regimens deliver a lower biologically equivalent radiation dose than the conventional regimens used for younger adults. Whether dose escalated hypofractionation can further improve outcomes in older adults remains unclear.\n\nThis will be a hybrid randomized control trial comparing the efficacy and safety of dose-escalated and standard hypofractionated radiotherapy among older adults with newly-diagnosed glioblastoma compared to standard three-week course. This research study involves the administration of radiation therapy. Radiation will either be delivered at the standard daily dose or at an increased daily dose over a three weeks course of radiation treatment.\n\nResearch study procedures will include a screening evaluation to assess eligibility, as well as clinical visits for radiation delivery and to assess symptoms during treatment and at scheduled follow-up times.\n\nParticipants will be randomly assigned to one of the two arms of the trial:\n\n1. Standard hypofractionated radiation over 3 weeks\n2. Dose-escalated hypofractionated radiation over 3 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histological confirmation of WHO grade 4 glioblastoma (IDH wild-type by immunohistochemistry or sequencing). Histopathology must be confirmed by central review.\n* Newly diagnosed disease, with time elapsed from diagnostic surgery/resection \\<8 weeks.\n* Age ≥ 65 years old at time of glioblastoma diagnosis\n* Adequate functional status as measured by a ECOG Performance Status 0, 1 or 2, at time of enrollment.\n* Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 45 days prior to randomization:\n\nPlatelet count ≥ 100 x 10\\^9/L (100,000 cells/mm\\^3) Serum creatinine ≤ 1.5 times the upper limit of normal Total serum bilirubin ≤ 1.5 times the upper limit of normal ALT (SGPT) \\< 2.5 times the upper limit of normal and/or AST (SGOT) \\< 2.5 times the upper limit of normal\n\n-Patient may have received corticosteroids, but must be on a stable or decreasing dose for at least 14 days prior to randomization.\n\nExclusion Criteria:\n\n* Participants with recurrent glioma.\n* Participants with evidence of spinal, leptomeningeal, or more distant disease.\n* Participants with another active central nervous system malignancies requiring treatment.\n* Participants with a second invasive malignancy that is A) incompletely treated or requiring ongoing treatment, or B) reasonably anticipated to be associated with a median overall survival of less than 1 year based on population-level data for the specified disease site and stage.\n* Participants with any other major medical illnesses or psychiatric treatments that in the treating physician's opinion will prevent administration or completion of protocol therapy.\n* Participants with inadequate mental capacity to provide informed consent\n* Participants who cannot receive gadolinium\n* Participants who have undergone prior head and neck or cranial radiation or radiation to any other site previously that would be reasonably anticipated to result in a significant overlap in radiation fields.\n* Participants who have received systemic or radiosensitizing therapy for a prior head and neck or central nervous system malignancy or any investigational cancer drug for glioblastoma prior to randomization.\n* Participants who have received or plan to receive any other form of non-surgical local or field treatment overlapping with the anticipated radiation field.\n* Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) or other acute medical conditions at the time of randomization that would impair the ability of the patient to receive protocol treatment."}, 'identificationModule': {'nctId': 'NCT06835803', 'acronym': 'ELITE-GBM', 'briefTitle': 'Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma (ELITE-GBM): A Phase 2 Hybrid Randomized Trial Leveraging External Data', 'orgStudyIdInfo': {'id': '24-637'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose-escalated hypofractionated radiation over 3 weeks', 'interventionNames': ['Radiation: Dose-escalated radiation therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard hypofractionated radiation over 3 weeks', 'interventionNames': ['Radiation: Standard hypofractionated radiation']}], 'interventions': [{'name': 'Dose-escalated radiation therapy', 'type': 'RADIATION', 'description': 'Dose-escalated radiation therapy involves higher doses of radiation therapy each day of treatment over the three week course of radiation therapy', 'armGroupLabels': ['Dose-escalated hypofractionated radiation over 3 weeks']}, {'name': 'Standard hypofractionated radiation', 'type': 'RADIATION', 'description': 'Standard hypofractionated radiation therapy over 3 weeks', 'armGroupLabels': ['Standard hypofractionated radiation over 3 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rifaquat Rahman, MD', 'role': 'CONTACT', 'email': 'rrahman@bwh.harvard.edu', 'phone': '6177325500'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01757', 'city': 'Milford', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Monica Krishnan, MD', 'role': 'CONTACT', 'email': 'mkrishnan@bwh.harvard.edu', 'phone': '5084883800'}], 'facility': 'Dana-Farber Brigham Cancer Center, Milford Hospital', 'geoPoint': {'lat': 42.13982, 'lon': -71.51617}}, {'zip': '02190', 'city': 'South Weymouth', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anurag Saraf, MD', 'role': 'CONTACT', 'email': 'anurag_saraf@dfci.harvard.edu', 'phone': '7816244710'}], 'facility': 'Dana-Farber Brigham Cancer Center, South Shore Hospital', 'geoPoint': {'lat': 42.1751, 'lon': -70.94949}}], 'centralContacts': [{'name': 'Rifaquat Rahman, MD', 'role': 'CONTACT', 'email': 'rrahman@bwh.harvard.edu', 'phone': '617-732-6682'}, {'name': 'Anurag Saraf, MD', 'role': 'CONTACT', 'email': 'anurag_saraf@dfci.harvard.edu', 'phone': '781-624-4700'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We will plan to share IPD pending securing funding to facilitate data-sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rifaquat M. Rahman, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}