Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-01 @ 4:13 PM
Study NCT ID:
NCT02397733
Status:
COMPLETED
Last Update Posted:
2021-08-02
First Post:
2015-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Memory Preservation of Prophylactic Cranial Irradiation With Hippocampal Avoidance (PREMER-TRIAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2015-03-20', 'studyFirstSubmitQcDate': '2015-03-20', 'lastUpdatePostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)', 'timeFrame': 'Change from baseline to 3 months', 'description': 'Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 3 months after radiation'}], 'secondaryOutcomes': [{'measure': 'Neurocognitive functioning (NCF) (Free and Cued Selective Reminding Test)', 'timeFrame': 'Change from baseline to 6,12 and 24 months', 'description': 'Free and Cued Selective Reminding Test (FCSRT) evaluated at baseline and 6,12 and 24 months after radiation'}, {'measure': 'Hippocampus brain metastases (brain magnetic resonance imaging) (MRI)', 'timeFrame': 'Change from baseline to 3, 6,12 and 24 months', 'description': 'Evaluation of hippocampus brain metastases at 3, 6, 12 and 24 months after radiation'}, {'measure': 'Hippocampus volume (brain magnetic resonance imaging) (MRI)', 'timeFrame': 'Change from baseline to 3, 6,12 and 24 months', 'description': 'Evaluation of hippocampus volume at 3, 6, 12 and 24 months after radiation'}, {'measure': 'Adverse effects (according to Common Toxicity Criteria for Adverse Effects)', 'timeFrame': 'Change from baseline to 3, 6,12 and 24 months', 'description': 'Evaluation of adverse effects according to Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) version 4.0 at 3, 6, 12 and 24 months after radiation'}, {'measure': 'Quality of life (measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire (QLQ C-30 and QLQ BN-20)', 'timeFrame': 'Change from baseline to 3, 6,12 and 24 months', 'description': 'Evaluation of Quality of Life (QoL) measured by European Organization for Research and Treatment of Cancer (EORTC) questionnaire (QLQ C-30 and QLQ BN-20)'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 5 years', 'description': 'From the start date of PCI until the date of death from any cause, or the last follow-up date whichever came first, assessed up to 60months"'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Carcinoma']}, 'referencesModule': {'references': [{'pmid': '39615412', 'type': 'DERIVED', 'citation': 'Zeng H, Schagen SB, Hendriks LEL, Sanchez-Benavides G, Jaspers JPM, Manero RM, Lievens Y, Murcia-Mejia M, Kuenen M, Rico-Oses M, Albers EAC, Samper P, Houben R, de Ruiter MB, Dieleman EMT, Lopez-Guerra JL, De Jaeger K, Counago F, Lambrecht M, Calvo-Crespo P, Belderbos JSA, De Ruysscher DKM, Rodriguez de Dios N. Impact of HA-PCI on self-reported cognitive functioning and brain metastases in small-cell lung cancer: Pooled findings of NCT01780675 and PREMER trials. Lung Cancer. 2025 Jan;199:108036. doi: 10.1016/j.lungcan.2024.108036. Epub 2024 Nov 23.'}, {'pmid': '34632876', 'type': 'DERIVED', 'citation': 'Ishibashi A, Kurosaki H, Miura K, Utsumi N, Sakurai H. Influence of Modulation Factor on Treatment Plan Quality and Irradiation Time in Hippocampus-Sparing Whole-Brain Radiotherapy Using Tomotherapy. Technol Cancer Res Treat. 2021 Jan-Dec;20:15330338211045497. doi: 10.1177/15330338211045497.'}, {'pmid': '34379442', 'type': 'DERIVED', 'citation': 'Rodriguez de Dios N, Counago F, Murcia-Mejia M, Rico-Oses M, Calvo-Crespo P, Samper P, Vallejo C, Luna J, Trueba I, Sotoca A, Cigarral C, Farre N, Manero RM, Duran X, Gispert JD, Sanchez-Benavides G, Rognoni T, Torrente M, Capellades J, Jimenez M, Cabada T, Blanco M, Alonso A, Martinez-San Millan J, Escribano J, Gonzalez B, Lopez-Guerra JL. Randomized Phase III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small-Cell Lung Cancer (PREMER): A GICOR-GOECP-SEOR Study. J Clin Oncol. 2021 Oct 1;39(28):3118-3127. doi: 10.1200/JCO.21.00639. Epub 2021 Aug 11.'}, {'pmid': '29891263', 'type': 'DERIVED', 'citation': 'Rodriguez de Dios N, Counago F, Lopez JL, Calvo P, Murcia M, Rico M, Vallejo C, Luna J, Trueba I, Cigarral C, Farre N, Manero RM, Duran X, Samper P. Treatment Design and Rationale for a Randomized Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for SCLC: PREMER Trial on Behalf of the Oncologic Group for the Study of Lung Cancer/Spanish Radiation Oncology Group-Radiation Oncology Clinical Research Group. Clin Lung Cancer. 2018 Sep;19(5):e693-e697. doi: 10.1016/j.cllc.2018.05.003. Epub 2018 May 10.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study i sto evaluate the impact of prophylactic cranial irradiation (PCI) with hippocampal avoidance in the neurocognitive function and quality of life of small cell lung cancer patients.\n\nIn addition, the trial assesses the potential changes in hippocampal volumetry due to cranial irradiation using magnetic resonance imaging.', 'detailedDescription': 'Prophylactic cranial irradiation (PCI) has become a standard of care for selected patients with limited and extensive stage small cell lung cancer (SCLC) who have shown benefit after chemotherapy with or without thoracic radiotherapy.\n\nBecause hippocampal involvement by metastatic disease is rare, and because preclinical and clinical evidence suggests that radiation dose received by the hippocampus during whole brain radiotherapy may play a role in radiation-induced neurocognitive decline, sparing of the hippocampus during the administration of PCI should result in lower rates of memory loss.\n\nPrevious studies have demonstrated the dosimetric capabilities of intensity modulated radiation therapy (IMRT) to conformably avoid the hippocampus without detriment to the radiation dose the remaining brain receives.\n\nThe main objective of this trial is compare neurocognitive functioning following hippocampal avoidance PCI to standard PCI treatment measured by Free and Cued Selective Reminding Test (FCSRT). The FCSRT measures verbal learning and memory. The FCSRT emphasizes encoding specificity during learning and recall. One of the secondary objectives of this trial is to test the hypothesis that the lowered neurocognitive function of the patients is due to a substantial reduction in hippocampal volume in magnetic resonance imaging (MRI). Others objectives are to evaluate quality of life (QoL) and the rate of metastases in the hippocampus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New diagnosed cytological or histologically confirmed Small cell lung carcinoma (stage I-IV) candidate for PCI, for example, without progressive disease after chemo-radiotherapy in stage I-III or after response after chemotherapy in stage IV\n* Performance status ≤ 1\n* Negative MRI of the brain within one month before protocol entry\n* Patient must give written informed consent before registration\n\nExclusion Criteria:\n\n* Prior radiotherapy to the brain\n* History of brain metastases\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT02397733', 'briefTitle': 'Memory Preservation of Prophylactic Cranial Irradiation With Hippocampal Avoidance (PREMER-TRIAL)', 'nctIdAliases': ['NCT02357875'], 'organization': {'class': 'OTHER', 'fullName': 'Grupo de Investigación Clínica en Oncología Radioterapia'}, 'officialTitle': 'Phase III Trial Evaluating Memory Preservation of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in Small Cell LUNG Cancer (PREMER-TRIAL)', 'orgStudyIdInfo': {'id': 'PREMER-TRIAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prophylactic cranial irradiation (PCI)', 'description': 'Radiation. Prophylactic cranial irradiation : 25 Gy in 10 daily fractions, five times a week', 'interventionNames': ['Radiation: Prophylactic cranial irradiation (PCI)']}, {'type': 'EXPERIMENTAL', 'label': 'Hippocampal avoidance PCI', 'description': 'Hippocampal avoidance prophylactic cranial irradiation. 25 Gy in 10 daily fractions, five times a week', 'interventionNames': ['Radiation: Hippocampal avoidance PCI']}], 'interventions': [{'name': 'Prophylactic cranial irradiation (PCI)', 'type': 'RADIATION', 'description': 'Prophylactic cranial irradiation (PCI): 25 Gy in 10 daily fractions, five times a week', 'armGroupLabels': ['Prophylactic cranial irradiation (PCI)']}, {'name': 'Hippocampal avoidance PCI', 'type': 'RADIATION', 'description': 'Hippocampal avoidance prophylactic cranial irradiation 25 Gy in 10 daily fractions, five times a week', 'armGroupLabels': ['Hippocampal avoidance PCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08009', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Del Mar. Radiation Oncology Department', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Núria Rodríguez de Dios, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': '+34683375231'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo de Investigación Clínica en Oncología Radioterapia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nuria Rodriguez de Dios', 'investigatorAffiliation': 'Grupo de Investigación Clínica en Oncología Radioterapia'}}}}