Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 6:55 AM
Study NCT ID:
NCT05203250
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Registry Including Patients Treated With Heavy Particles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '50 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2071-06-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Real world data collection', 'timeFrame': '50 years', 'description': 'To collect real world data of patients treated with radiotherapy, to support particle radiotherapy and to provide evidence of the role of radiation oncology within the multidisciplinary approach.'}], 'secondaryOutcomes': [{'measure': 'Disease evolution', 'timeFrame': '50 years', 'description': 'To analyze the disease course and treatment performed by collecting demographic, disease characteristics and delivered treatment'}, {'measure': 'Predicitive models', 'timeFrame': '50 years', 'description': 'To collect details about the radiation treatment and radiobiological parameters to develop predictive models (outcome and toxicity)'}, {'measure': 'Outcome data', 'timeFrame': '50 years', 'description': 'To collect outcome data (in terms of overall survival, progression free-survival and local control) and to correlate them with the delivered treatment'}, {'measure': 'Toxicities', 'timeFrame': '50 years', 'description': 'To define acute, intermediate and late toxicities, according to CTCAE v 5.0 and to correlate it with the delivered treatment'}, {'measure': 'QoL', 'timeFrame': '50 years', 'description': 'To collect data on standardized QoL questionnaires and PROMS (e,g EORTC C30, EQDL) at 6, 12. 18, 24, 36 months and to correlate them with the delivered treatment'}, {'measure': 'Future research', 'timeFrame': '50 years', 'description': 'To generate hypotheses for further research'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hadrontherapy', 'Oncology', 'Cancer', 'Radiotherapy', 'Protons', 'Carbon Ions', 'Heavy ions', 'Rare cancer'], 'conditions': ['Cancer', 'Oncology', 'Radiation Exposure', 'Radiotherapy Side Effect', 'Radiation Toxicity', 'Rare Disease']}, 'referencesModule': {'references': [{'pmid': '33080914', 'type': 'BACKGROUND', 'citation': 'Tinganelli W, Durante M. Carbon Ion Radiobiology. Cancers (Basel). 2020 Oct 17;12(10):3022. doi: 10.3390/cancers12103022.'}, {'pmid': '27540827', 'type': 'BACKGROUND', 'citation': 'Durante M, Paganetti H. Nuclear physics in particle therapy: a review. Rep Prog Phys. 2016 Sep;79(9):096702. doi: 10.1088/0034-4885/79/9/096702. Epub 2016 Aug 19.'}, {'pmid': '2154042', 'type': 'BACKGROUND', 'citation': 'Kraft G. The radiobiological and physical basis for radiotherapy with protons and heavier ions. Strahlenther Onkol. 1990 Jan;166(1):10-3.'}, {'pmid': '8103540', 'type': 'BACKGROUND', 'citation': 'Weber KJ, Flentje M. Lethality of heavy ion-induced DNA double-strand breaks in mammalian cells. Int J Radiat Biol. 1993 Aug;64(2):169-78. doi: 10.1080/09553009314551261.'}, {'pmid': '22321201', 'type': 'BACKGROUND', 'citation': 'Mizoe JE, Hasegawa A, Jingu K, Takagi R, Bessyo H, Morikawa T, Tonoki M, Tsuji H, Kamada T, Tsujii H, Okamoto Y; Organizing Committee for the Working Group for Head Neck Cancer. Results of carbon ion radiotherapy for head and neck cancer. Radiother Oncol. 2012 Apr;103(1):32-7. doi: 10.1016/j.radonc.2011.12.013. Epub 2012 Feb 8.'}, {'pmid': '32753239', 'type': 'BACKGROUND', 'citation': 'Weber DC, Langendijk JA, Grau C, Thariat J. Proton therapy and the European Particle Therapy Network: The past, present and future. Cancer Radiother. 2020 Oct;24(6-7):687-690. doi: 10.1016/j.canrad.2020.05.002. Epub 2020 Aug 1.'}, {'pmid': '30056852', 'type': 'BACKGROUND', 'citation': 'Langendijk JA, Orecchia R, Haustermans K, Zips D, Balosso J, Lacombe D, Lievens Y, Weber DC, Grau C, Troost EGC. Prospective data registration and clinical trials for particle therapy in Europe. Radiother Oncol. 2018 Jul;128(1):9-13. doi: 10.1016/j.radonc.2018.06.001. Epub 2018 Jul 7.'}, {'pmid': '32223048', 'type': 'RESULT', 'citation': 'Grau C, Durante M, Georg D, Langendijk JA, Weber DC. Particle therapy in Europe. Mol Oncol. 2020 Jul;14(7):1492-1499. doi: 10.1002/1878-0261.12677. Epub 2020 Apr 22.'}], 'seeAlsoLinks': [{'url': 'https://fondazionecnao.it/en/', 'label': 'CNAO website'}]}, 'descriptionModule': {'briefSummary': "The purpose of this registry is to collect retrospective and prospective standardized data of patients treated with particle therapy, either with protons or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO) based in Pavia.\n\nBy keeping track of the patients treated, it will allow the investigators to periodically analyze and evaluate data collected of daily clinical activity. This will help gathering more information on the results of particle therapy and will provide the basis for in depth evaluation of patients' outcome with respect to the delivered treatment.", 'detailedDescription': 'Hadrontherapy is a unique radiotherapy (RT) that uses positively charged particles, namely protons and carbons, rather than photons used in conventional RT, to treat cancer.\n\nParticle therapy represents a coming together of physics research applied to oncology and it is currently the most advanced form of radiotherapy for the treatment of tumors that are particularly radio resistant or located nearby sensitive structures.The strength of hadrontherapy lies in the unique physical and radiobiological properties of these particles. Indeed, protons and carbon ions have several biological advantages compared to conventional photon radiotherapy.\n\nIn this scenario we aim at constructing a patient registry to retrospectively and prospectively collect real-world data on all cancer patients treated at CNAO, either with protons or carbon ion radiation, independently of their disease (multiple cohorts will be included) for which they were treated.\n\nWe aim at collecting data on the natural history of the disease (how the disease presents, develops and progress, its association with other conditions). Those data will allow us to assess prognostic and predictive factors to evaluate treatment effects and toxicities and to provide evidence of the role of radiation oncology in a multidisciplinary approach.\n\nSuch registry will be used to generate clinical evidence and high-quality data that could better define the indications for heavy particles therapy and become a resource for the wider scientific community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated with particle therapy, protons and/or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO), based in Pavia, who have signed the written informed consent document, can be enrolled in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with heavy particles at Fondazione CNAO, Pavia\n* Patients who have the ability to understand and be willing to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients or legal guardians who are unable to understand informed consent document'}, 'identificationModule': {'nctId': 'NCT05203250', 'briefTitle': 'Longitudinal Registry Including Patients Treated With Heavy Particles', 'organization': {'class': 'OTHER', 'fullName': 'CNAO National Center of Oncological Hadrontherapy'}, 'officialTitle': 'CNAO REgistry triAL - REGAL', 'orgStudyIdInfo': {'id': 'CNAO OSS 25 2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Brain tumors, skull base tumors, spinal cord tumors', 'description': 'NEUROPARTICLE', 'interventionNames': ['Radiation: Heavy-ion therapy (hadrontherapy)']}, {'label': 'Ocular melanomas', 'interventionNames': ['Radiation: Heavy-ion therapy (hadrontherapy)']}, {'label': 'Head and Neck tumors', 'interventionNames': ['Radiation: Heavy-ion therapy (hadrontherapy)']}, {'label': 'Tumors of thorax and/or abdomen', 'description': 'GI-Particle', 'interventionNames': ['Radiation: Heavy-ion therapy (hadrontherapy)']}, {'label': 'Pelvic tumors', 'description': 'GYN-Particle', 'interventionNames': ['Radiation: Heavy-ion therapy (hadrontherapy)']}, {'label': 'Sarcomas and tumors of limbs', 'description': 'SarTAP-Particle', 'interventionNames': ['Radiation: Heavy-ion therapy (hadrontherapy)']}, {'label': 'Pediatric tumors', 'interventionNames': ['Radiation: Heavy-ion therapy (hadrontherapy)']}, {'label': 'Mobile spine and sacral tumors', 'interventionNames': ['Radiation: Heavy-ion therapy (hadrontherapy)']}], 'interventions': [{'name': 'Heavy-ion therapy (hadrontherapy)', 'type': 'RADIATION', 'description': 'Only data available from routine clinical practice at the National Center for Oncological Hadrontherapy (CNAO), based Pavia, will be collected. Intervention is not assigned.', 'armGroupLabels': ['Brain tumors, skull base tumors, spinal cord tumors', 'Head and Neck tumors', 'Mobile spine and sacral tumors', 'Ocular melanomas', 'Pediatric tumors', 'Pelvic tumors', 'Sarcomas and tumors of limbs', 'Tumors of thorax and/or abdomen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Campo, PhD', 'role': 'CONTACT', 'email': 'campo@cnao.it', 'phone': '+39 0382-078 407'}, {'name': 'Cristina Bono', 'role': 'CONTACT', 'email': 'bono@cnao.it', 'phone': '+39 0382078613'}, {'name': 'Ester Orlandi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Center for Oncological Hadrontherapy (CNAO)', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Chiara Campo, PhD', 'role': 'CONTACT', 'email': 'campo@cnao.it', 'phone': '+39 0382078407'}, {'name': 'Cristina Bono', 'role': 'CONTACT', 'email': 'bono@cnao.it', 'phone': '+39 0382078613'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CNAO National Center of Oncological Hadrontherapy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}