Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT01811394
Status:
UNKNOWN
Last Update Posted:
2023-12-06
First Post:
2013-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ion Irradiation of Sacrococcygeal Chordoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002817', 'term': 'Chordoma'}], 'ancestors': [{'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011522', 'term': 'Protons'}], 'ancestors': [{'id': 'D002414', 'term': 'Cations, Monovalent'}, {'id': 'D002412', 'term': 'Cations'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D006859', 'term': 'Hydrogen'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D000071940', 'term': 'Nucleons'}, {'id': 'D004601', 'term': 'Elementary Particles'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2013-03-09', 'studyFirstSubmitQcDate': '2013-03-12', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique', 'timeFrame': 'From date of treatment start until 12 months after treatment.', 'description': 'The evaluation is based on incidence of Grade 3-5 toxicity (NCI-CTC-AE) and/or discontinuation of the treatment for any reason. Endpoint is the proportion of treatments without Grade 3-5 toxicity (NCI-CTC-AE) up to 12 months after treatment and/or discontinuation of the treatment for any reason'}], 'secondaryOutcomes': [{'measure': 'local progression free survival (LPFS)', 'timeFrame': 'From date of treatment start until the date of first documented progression in MRI/CT scan assessed up to 12 months.', 'description': 'local progression free survival (LPFS) is determined from start of treatment until local progression in imaging (\\>10% size increase)'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From date of treatment start until the date of death from any cause assessed up to 12 months.', 'description': 'Further objectives are overall survival (OS) from date of treatment start until the date of death from any cause assessed up to 12 months'}, {'measure': 'Quality of life (QoL)', 'timeFrame': 'From date of treatment start up to 12 months. Evaluation at treatment start, at the end of treatment and 12 months after treatment.', 'description': 'Quality of life (QoL) evaluated with EORTC-QLQ30 questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sacral chordoma', 'chordoma', 'carbon ion therapy', 'proton therapy', 'hypofractionation'], 'conditions': ['Sacral Chordoma']}, 'referencesModule': {'references': [{'pmid': '24774721', 'type': 'BACKGROUND', 'citation': 'Uhl M, Edler L, Jensen AD, Habl G, Oelmann J, Roder F, Jackel O, Debus J, Herfarth K. Randomized phase II trial of hypofractionated proton versus carbon ion radiation therapy in patients with sacrococcygeal chordoma-the ISAC trial protocol. Radiat Oncol. 2014 Apr 29;9:100. doi: 10.1186/1748-717X-9-100.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of sacrococcygeal chordoma with carbon ions or protons using the raster scan technique.', 'detailedDescription': 'The primary objective of this trial is safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using protons or carbon ions in raster scan technique for primary or additive treatment after R2 resection. The evaluation is therefore based on the proportion of treatments without Grade 3-5 toxicity (CTCAE, version 4.0) up to 12 months after treatment and/or discontinuation of the treatment for any reason as primary endpoint. Local-progression free survival, overall survival and quality of life will be analyzed as secondary end points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological confirmation of sacrococcygeal chordoma\n* Karnofsky performance status ≥ 70%\n* Patients age 18 - 80 years\n* Macroscopic tumour (MRI)\n* Written informed consent\n\nExclusion Criteria:\n\n* Lack of macroscopic tumour\n* Tumor extension in craniocaudal direction \\>16cm\n* Metal implants at the level of the tumor which could influence the treatment planning\n* Inability of the patient to lie quiet for at least 20 minutes (eg due to pain)\n* Prior radiotherapy of the pelvic region\n* Simultaneous participation in another trial that could influence the results of the study\n* Active medical implants without treatment approval at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)'}, 'identificationModule': {'nctId': 'NCT01811394', 'acronym': 'ISAC', 'briefTitle': 'Ion Irradiation of Sacrococcygeal Chordoma', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Hypofractionated Ion Irradiation (Protons or Carbon Ions) of Sacrococcygeal Chordoma', 'orgStudyIdInfo': {'id': 'ISAC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'protons', 'description': '16x4GyE protons', 'interventionNames': ['Radiation: protons']}, {'type': 'EXPERIMENTAL', 'label': 'Carbon ions', 'description': '16x4GyE carbon ions', 'interventionNames': ['Radiation: carbon ions']}], 'interventions': [{'name': 'protons', 'type': 'RADIATION', 'description': 'Treatment is performed using 16 x 4 GyE protons', 'armGroupLabels': ['protons']}, {'name': 'carbon ions', 'type': 'RADIATION', 'description': 'Treatment is performed using 16 x 4 GyE carbon ions', 'armGroupLabels': ['Carbon ions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69125', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University of Heidelberg, Radiooncology, HIT', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Klaus Herfarth, MD', 'investigatorAffiliation': 'Heidelberg University'}}}}