Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06283927
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D008130', 'term': 'Lomustine'}, {'id': 'D000069475', 'term': 'Re-Irradiation'}, {'id': 'D035703', 'term': 'Therapies, Investigational'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D050130', 'term': 'Oncolytic Virotherapy'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019233', 'term': 'Retreatment'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 464}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 5 years postoperatively', 'description': 'Time from diagnosis to death from any cause'}, {'measure': 'Neurological morbidity at 6 weeks', 'timeFrame': '6 weeks postoperatively', 'description': 'NIHSS deterioration of 1 point or more at 6 weeks after surgery'}], 'secondaryOutcomes': [{'measure': 'Neurological morbidity at 3 months', 'timeFrame': '3 months postoperatively', 'description': 'NIHSS deterioration of 1 point or more at 3 months after surgery'}, {'measure': 'Neurological morbidity at 6 months', 'timeFrame': '6 months postoperatively', 'description': 'NIHSS deterioration of 1 point or more at 6 months after surgery'}, {'measure': 'Progression-free survival', 'timeFrame': 'Up to 5 years postoperatively', 'description': 'Time from diagnosis to disease progression (occurrence of a new tumor lesions with a volume greater than 0.175 cm3, or an increase in residual tumor volume of more than 25%) or death, whichever comes first'}, {'measure': 'Residual tumor volume', 'timeFrame': 'Within 72 hours postoperatively', 'description': 'Residual tumor volume of the contrast-enhancing and non-contrast enhancing part, as assessed by a neuroradiologist on postoperative MRI scan (T1 with contrast and FLAIR sequences) using manual or semi-automatic volumetric analyses (Brainlab Elements iPlan CMF Segmentation, Brainlab AG, Munich, Germany; or similar software)'}, {'measure': 'Quality of life at 6 weeks (EORTC QLQ C30)', 'timeFrame': '6 weeks postoperatively', 'description': 'Quality of life as assessed by the EORTC QLQ C30 questionnaire'}, {'measure': 'Quality of life at 3 months (EORTC QLQ C30)', 'timeFrame': '3 months postoperatively', 'description': 'Quality of life as assessed by the EORTC QLQ C30 questionnaire'}, {'measure': 'Quality of life at 6 months (EORTC QLQ C30)', 'timeFrame': '6 months postoperatively', 'description': 'Quality of life as assessed by the EORTC QLQ C30 questionnaire'}, {'measure': 'Quality of life at 6 weeks (EORTC QLQ BN20)', 'timeFrame': '6 weeks postoperatively', 'description': 'Quality of life as assessed by the EORTC QLQ BN20 questionnaire'}, {'measure': 'Quality of life at 3 months (EORTC QLQ BN20)', 'timeFrame': '3 months postoperatively', 'description': 'Quality of life as assessed by the EORTC QLQ BN20 questionnaire'}, {'measure': 'Quality of life at 6 months (EORTC QLQ BN20)', 'timeFrame': '6 months postoperatively', 'description': 'Quality of life as assessed by the EORTC QLQ BN20 questionnaire'}, {'measure': 'Quality of life at 6 weeks (EQ-5D)', 'timeFrame': '6 weeks postoperatively', 'description': 'Quality of life as assessed by the EQ-5D questionnaire'}, {'measure': 'Quality of life at 3 months (EQ-5D)', 'timeFrame': '3 months postoperatively', 'description': 'Quality of life as assessed by the EQ-5D questionnaire'}, {'measure': 'Quality of life at 6 months (EQ-5D)', 'timeFrame': '6 months postoperatively', 'description': 'Quality of life as assessed by the EQ-5D questionnaire'}, {'measure': 'Serious Adverse Events', 'timeFrame': '6 weeks postoperatively', 'description': 'Serious Adverse Events within 6 weeks postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glioblastoma', 'Radiotherapy', 'Chemotherapy', 'Re-resection', 'Resection', 'Overall survival', 'Progression-free survival', 'Neurological morbidity', 'Safety', 'Serious Adverse Events', 'Quality of life'], 'conditions': ['Glioblastoma', 'Glioblastoma Multiforme', 'Glioblastoma, IDH-wildtype', 'Glioblastoma Multiforme of Brain', 'Glioblastoma Multiforme, Adult', 'Recurrent Glioblastoma', 'Astrocytoma, Malignant', 'Astrocytoma of Brain']}, 'descriptionModule': {'briefSummary': 'Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups.\n\nThis study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.\n\nThe study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.', 'detailedDescription': 'This is an international, multicenter, prospective, cohort study. Eligible patients are operated or receive best oncological treatment with a 1:1 ratio with a sequential computer-generated random number as subject ID. Intraoperative mapping techniques and/or surgical adjuncts can be used in both treatment arms to ensure the safety of the resection (to minimize the risk of postoperative deficits).\n\nStudy patients undergo tumor re-resection or receive best oncological treatment and will undergo evaluation at presentation (baseline) and during the follow-up period at 6 weeks, 3 months, and 6 months postoperatively. Motor function will be evaluated using the NIHSS (National Institute of Health Stroke Scale) and MRC (Medical Research Council) scale. Language function will be evaluated using a standard neurolinguistic test-battery consisting of the Aphasia Bedside Check (ABC), Shortened Token test, Verbal fluency, Picture description and Object naming. This neurolinguistic test-battery is the result of a consensus between the participating centers. Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). Overall patient functioning with be assessed with the Karnofsky Performance Scale (KPS) and the ASA (American Society of Anesthesiologists) physical status classification system for comorbidities. Health-related quality of life (HRQoL) will be assessed with the EQ-5D questionnaire and the EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. Overall survival and progression-free survival will be assessed. We expect to complete patient inclusion in 4 years. The estimated duration of the study, including follow-up, will be 5 years.\n\nThe primary study objective is to evaluate the safety and efficacy of re-resection versus best oncological treatment (neurological morbidity and overall survival) in recurrent glioblastoma patients as expressed by NIHSS scores and survival data. Secondary study objectives are to study the overall progressive-free survival (PFS), long-term neurological morbidity (3 months and 6 months postoperatively), health-related quality of life (HRQoL), and Serious Adverse Events (SAEs) after resection versus best oncological treatment as expressed by progression on follow up MRI scans based on the RANO criteria24 for tumor progression; NIHSS scores, quality of life questionnaires (EORTC QLQ C30, EORTC QLQ BN20, EQ-5D), and registration of SAEs.\n\nPatients will be recruited for the study from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals of the ENCRAM Research Consortium, located in Europe and the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with recurrent glioblastoma will be recruited from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals, located in Europe and the United States. The study is carried out by centers from the ENCRAM Consortium.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma\n3. The tumor is suitable for resection (according to neurosurgeon)\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem, or midline\n2. Medical reasons precluding MRI (e.g., pacemaker)\n3. Inability to give written informed consent\n4. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n5. Clinical data unavailable for the newly diagnosed setting'}, 'identificationModule': {'nctId': 'NCT06283927', 'acronym': 'RECSUR', 'briefTitle': 'The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2302)', 'orgStudyIdInfo': {'id': 'MEC-2020-0812-5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Re-resection', 'description': 'Resection of the recurrent tumor', 'interventionNames': ['Procedure: Re-resection']}, {'label': 'Best oncological treatment', 'description': 'Best oncological treatment consisting of re-challenge temozolomide, re-irradiation, experimental therapy, or best supportive care', 'interventionNames': ['Drug: Temozolomide', 'Drug: Lomustine', 'Radiation: Re-irradiation', 'Procedure: Experimental therapy', 'Other: Best supportive care']}], 'interventions': [{'name': 'Re-resection', 'type': 'PROCEDURE', 'description': 'Resection of the recurrent tumor', 'armGroupLabels': ['Re-resection']}, {'name': 'Temozolomide', 'type': 'DRUG', 'description': 'Re-challenge Temozolomide chemotherapy', 'armGroupLabels': ['Best oncological treatment']}, {'name': 'Lomustine', 'type': 'DRUG', 'description': 'Second line chemotherapy with Lomustine', 'armGroupLabels': ['Best oncological treatment']}, {'name': 'Re-irradiation', 'type': 'RADIATION', 'description': 'Re-irradiation with single dose, fractionated, or hypofractionated radiation of the recurrent tumor', 'armGroupLabels': ['Best oncological treatment']}, {'name': 'Experimental therapy', 'type': 'PROCEDURE', 'otherNames': ['Immunotherapy', 'Oncolytic virotherapy'], 'description': 'Experimental phase I therapy with oncolytic virotherapy or immunotherapy (this list is not exhaustive)', 'armGroupLabels': ['Best oncological treatment']}, {'name': 'Best supportive care', 'type': 'OTHER', 'description': 'Best supportive care, focused on alleviating symptoms', 'armGroupLabels': ['Best oncological treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mitchel Berger, MD PhD', 'role': 'CONTACT'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Nahed, MD PhD', 'role': 'CONTACT'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Steven De Vleeschouwer, MD PhD', 'role': 'CONTACT'}], 'facility': 'University Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christine Jungk, Dr. med.', 'role': 'CONTACT'}], 'facility': 'University Hospital Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Munich', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Arthur Wagner, MD', 'role': 'CONTACT'}], 'facility': 'Technical University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Arnaud Vincent, MD PhD', 'role': 'CONTACT', 'email': 'a.vincent@erasmusmc.nl', 'phone': '+31639428949'}, {'name': 'Jasper Gerritsen, MD', 'role': 'CONTACT', 'email': 'j.gerritsen@erasmusmc.nl', 'phone': '+31629119553'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '2261 CP', 'city': 'The Hague', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marike Broekman, MD PhD', 'role': 'CONTACT', 'email': 'm.broekman@haaglandenmc.nl', 'phone': '+31639758253'}], 'facility': 'Medical Center Haaglanden', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Bern', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Philippe Schucht, MD PhD', 'role': 'CONTACT'}], 'facility': 'Inselspital Universitätsspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Jasper Gerritsen, MD PhD', 'role': 'CONTACT', 'email': 'j.gerritsen@erasmusmc.nl', 'phone': '31107036130'}, {'name': 'Arnaud Vincent, MD PhD', 'role': 'CONTACT', 'email': 'a.vincent@erasmusmc.nl', 'phone': '31107034211'}], 'overallOfficials': [{'name': 'Jasper Gerritsen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jasper Gerritsen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Haaglanden Medical Centre', 'class': 'OTHER'}, {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, {'name': 'Technical University of Munich', 'class': 'OTHER'}, {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Jasper Gerritsen', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}