Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT05964569
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-21', 'size': 724246, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-25T07:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, observer blind two arm (active control), parallel group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2028-11-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-07-19', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of contrast enhancing brain leasions', 'timeFrame': 'observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain', 'description': 'the cumulative incidence of contrast enhancing brain lesions'}], 'secondaryOutcomes': [{'measure': 'radiation-induced brain injuries', 'timeFrame': 'observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain', 'description': 'incidence of radiation-induced brain injuries \\> CTC°II'}, {'measure': 'progression-free survival', 'timeFrame': 'observed within 24 months after PRT measured by quarterly contrast enhanced MRI of the brain', 'description': 'number of surviving patients without tumor progression'}, {'measure': 'overall survival', 'timeFrame': 'observed within 24 months after Proton Beam Therapy (PRT) measured by quarterly contrast enhanced MRI of the brain', 'description': 'number of surviving patients'}, {'measure': 'patient reported outcome', 'timeFrame': 'up to 24 months after completion of radiotherapy', 'description': 'patient reported outcome according to points on the PRO-CTCAE questionaire, scored 0/1 for absent/present)'}, {'measure': 'quality of life QLQ-C30', 'timeFrame': 'up to 24 months after completion of PRT', 'description': 'scores on the QLQ-C30 questionare, scored 0 (absence) to 5 (fully present)'}, {'measure': 'quality of life QLQ-BN20', 'timeFrame': 'up to 24 months after completion of PRT', 'description': 'scores on the QLQ-BN20 questionare, scored 0 (absence) to 5 (fully present)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Grade Glioma']}, 'descriptionModule': {'briefSummary': 'Low-grade glioma (LGG) represent typically slowly growing primary brain tumors with world health organization (WHO) grade I or II who affect young adults around their fourth decade. Radiological feature on MRI is a predominantly T2 hyperintense signal, LGG show typically no contrast uptake. Radiotherapy plays an important role in the treatment of LGG. However, not least because of the good prognosis with long term survivorship the timing of radiotherapy has been discussed controversially. In order to avoid long term sequelae such as neurocognitive impairment, malignant transformation or secondary neoplasms initiation was often postponed as long as possible', 'detailedDescription': "Since patients with low grade glioma are expected to become long-term survivors, the prevention of long-term sequelae is particularly important. In addition to disease progression, also treatment related side effects such as decline of neurocognitive function, endocrine impairment or sensorineural deficits can have a negative impact on patient's quality of life.\n\nOwing to the biophysical properties of protons with an inverse depth dose profile compared to photons and a steep dose fall of to the normal tissue, there is a strong rationale for the use of PRT in the treatment of patients with low-grade glioma. Although data from large randomized trials are still missing there is increasing evidence from smaller prospective trials and retrospective analyses that the expected advantages indeed transform into clinical advantages.\n\nHowever, in about 20 % of all patients, late contrast-enhancing brain lesions (CEBL) appear on follow-up MR images 6 - 24 months after treatment. At HIT in Heidelberg and at OncoRay in Dresden, CEBLs have been observed to occur at very distinct locations in the brain and relative to the treatment field. Retrospective analysis has elucidated potential key factors that lead to CEBL occurrence. However, avoidance of CEBLs is hardly feasible using conventional treatment planning strategies. Model-aided risk avoidance denotes the use of model-based CEBL risk calculations as an auxiliary tool for clinical treatment planning: Model-based risk calculations and risk reduction via software-based optimization help the clinician to minimize risk of CEBL occurrence during treatment planning."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* histologically proven low-grade glioma\n* indication for definitive or adjuvant radiotherapy\n* ability to understand character and personal consequences of the clinical trial\n* written informed consent\n\nExclusion Criteria:\n\n* previous cerebral irradiation\n* contraindication for contrast-enhanced MRI\n* neurofibromatosis\n* participation in another clinical trial with competing objectives'}, 'identificationModule': {'nctId': 'NCT05964569', 'acronym': 'INDIGO', 'briefTitle': 'Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Prospective Phase II Trial to Assess Feasibility of Individualized, Model-guided Optimization of Proton Beam Treatment Planning in Patients With Low Grade Glioma Multicentric, Prospective Interventional, Randomized, Observer Blind Two Arm (Active Control), Parallel Group Investigator-initiated Phase II Trial', 'orgStudyIdInfo': {'id': 'RadOnk-Indigo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment plan', 'description': 'Model-based NTCP is calculated after plan approval, however, no further adjustments are to be made to the approved treatment plan', 'interventionNames': ['Other: standard treatment plan, no optimization']}, {'type': 'EXPERIMENTAL', 'label': 'Optimized treatment plan', 'description': 'Allocated to Control Calculation of normal tissue complication probability (NTCP) Model-guided replanning. Replanning is performed with Raysearch Raystation. Optimizations objectives are:\n\n1. the optimization objectives that control the maximum dose in the target volume employ a variable, LETd-dependent model for RBE that allows us to include the RBE-variations predicted by the NTCP model\n2. the periventricular volume, defined as the volume closer than 4 mm to the ventricular wall, is included into the optimization with a constraint on its Equivalent Uniform Dose (EUD) and with the variable RBE model described above. Thereby, the combined effect of the RBE variation and increased sensitivity of the periventricular volume, as predicted by the NTCP model, is included.\n\nThe effectiveness of the re-planning is verified by a second NTCP computation.', 'interventionNames': ['Other: model-guided optimization of treatment plan']}], 'interventions': [{'name': 'model-guided optimization of treatment plan', 'type': 'OTHER', 'description': 'original treatmant plans are optimized based on model-based NTCP', 'armGroupLabels': ['Optimized treatment plan']}, {'name': 'standard treatment plan, no optimization', 'type': 'OTHER', 'description': 'original treatment plans are not optimized', 'armGroupLabels': ['Standard treatment plan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Juergen Debus, Prof. Dr. Dr.', 'role': 'CONTACT', 'email': 'juergen.debus@med.uni-heidelberg.de', 'phone': '+49 6221 56', 'phoneExt': '8200'}, {'name': 'Adriane Hommertgen, Dr. med.', 'role': 'CONTACT', 'email': 'adriane.hommertgen@med.uni-heidelberg.de', 'phone': '0622156', 'phoneExt': '34091'}], 'facility': 'Department of Radiotherapy, University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Semi Harrabi, MD', 'role': 'CONTACT', 'email': 'semi.harrabi@med.uni-heidelberg.de', 'phone': '+496221 56', 'phoneExt': '8201'}, {'name': 'Adriane Lentz-Hommertgen, Phd', 'role': 'CONTACT', 'email': 'adriane.lentz-hommertgen@med.uni-heidelberg.de', 'phone': '+496221 56', 'phoneExt': '8201'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department Head', 'investigatorFullName': 'Juergen Debus', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}