Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT04219202
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2020-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061766', 'term': 'Proton Therapy'}, {'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-05-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-03', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of grad 3-5 NCI-CTC-AE toxicities', 'timeFrame': 'within 12 month after radiation treatment', 'description': 'Evidence of the safety and practicability of the study treatment assessed for the incidence of grade 3-5 NCI-CTC-AE toxicity and / or termination of the planned therapy for any reason'}], 'secondaryOutcomes': [{'measure': 'local Tumor control', 'timeFrame': 'within 12 month after radiation treatment', 'description': 'Number of patients without new arising Tumors at the treated Tumor site'}, {'measure': 'local Progression free survival', 'timeFrame': 'within 12 month after radiation treatment', 'description': 'Number of patients without local Progression at the treated tumor site'}, {'measure': 'disease free survival', 'timeFrame': 'within 12 month after radiation treatment', 'description': 'Number of Patients without relapse of treated disease'}, {'measure': 'Overall survival', 'timeFrame': 'within 12 month after radiation treatment', 'description': 'Assesment of alive patients'}, {'measure': 'Quality of live', 'timeFrame': 'within 12 month after radiation treatment', 'description': 'Assessed by EORTC QLQ-C30, Minimum value 0; Maximum value 6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcoma,Soft Tissue']}, 'referencesModule': {'references': [{'pmid': '33579340', 'type': 'DERIVED', 'citation': 'Seidensaal K, Kieser M, Hommertgen A, Jaekel C, Harrabi SB, Herfarth K, Mechtesheimer G, Lehner B, Schneider M, Nienhueser H, Frohling S, Egerer G, Debus J, Uhl M. Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial. Trials. 2021 Feb 12;22(1):134. doi: 10.1186/s13063-021-05069-z.'}]}, 'descriptionModule': {'briefSummary': 'The study is a randomized, open, prospective phase II study. The aim of the study is to evaluate the safety and feasibility of a hypofractionated, accelerated radiation approach based on the incidence of grade 3-5 NCI Common Terminology Criteria for Adverse Events (NCI-CTC-AE ) toxicity and / or termination of the planned therapy for any reason with neoadjuvant radiation with active beam guidance of the retroperitoneal Sarcomas using protons or carbon ions before a subsequent tumor resection.', 'detailedDescription': 'With retroperitoneal sarcomas, the patient benefits from neoadjuvant radiotherapy. Due to the special physical properties of particles (protons and C12 carbon ions), in particular the steep lateral dose drop, an improved protection of adjacent risk organs is e.g. Intestine, kidneys, liver etc. during the process of applying radiotherapy is possible.\n\nThe primary study objective is to demonstrate the safety and conduct of study treatment and the incidence of Grade 3-5 NCI-CTC-AE toxicity and / or termination of preferred therapy for any reason. Further target parameter is the proportion of applied therapies without the occurance of degree 3-5 NCI-CTC-AE(s).\n\nThe patients are randomized 1: 1 into the two arms (carbon ions vs. protons). Patients receive 39 Gy in (SD 3.0 Gy) in 6 fractions per week.\n\nSecondary study objectives are local control (LC), local progression-free survival from the start of therapy (LPFS), disease-free survival (DFS), overall survival (OS) and quality of life (QoL) determined according to the EORTC-Quality of Life Questionaire (QLQ)- C30 questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable\n* Karnofsky index of ≥ 70%\n* Age from 18 years\n* Completed patient information and written consent\n* ability to give consent\n\nExclusion Criteria:\n\n* Stage IV (distant metastases)\n* Lymphogenic metastasis\n* Metal implants at the level of the sarcoma, which influence the treatment planning\n* Previous radiation therapy in the treatment area\n* Desmoid tumors, peritoneal sarcomatosis, GIST\n* Simultaneous participation in another clinical study that could influence the results of the respective study\n* Active medical implants for which there is no license for ion irradiation at the time of treatment (e.g. pacemaker, defibrillator)\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT04219202', 'acronym': 'Retro-Ion', 'briefTitle': 'Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie', 'orgStudyIdInfo': {'id': 'Rad-ONK Retro-Ion'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Proton Treatment', 'description': 'Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Proton Treatment', 'interventionNames': ['Radiation: Proton radiation']}, {'type': 'EXPERIMENTAL', 'label': 'Carbon Ion Treatment', 'description': 'Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Carbon Ion Treatment', 'interventionNames': ['Radiation: Carbon Ion radiation']}], 'interventions': [{'name': 'Proton radiation', 'type': 'RADIATION', 'description': 'Therapeutic radiation Treatment with Protons', 'armGroupLabels': ['Proton Treatment']}, {'name': 'Carbon Ion radiation', 'type': 'RADIATION', 'description': 'Therapeutic radiation Treatment with Carbon Ions', 'armGroupLabels': ['Carbon Ion Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Uhl, PD', 'role': 'CONTACT', 'email': 'Matthias.uhl@med.uni-heidelberg.de', 'phone': '+49-6221-56', 'phoneExt': '8202'}, {'name': 'Adriane Hommertgen', 'role': 'CONTACT', 'email': 'adriane.hommertgen@med.uni-heidelberg.de', 'phone': '+49-6221-56', 'phoneExt': '8202'}, {'name': 'Katharina Seidensaal, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Heidelberg, Radiation Oncology', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Juergen Debus, Prof.', 'role': 'CONTACT', 'email': 'juergen.debus@med.uni-heidelberg.de', 'phone': '+496221', 'phoneExt': '8201'}, {'name': 'Katharina Seidensaal, MD', 'role': 'CONTACT', 'email': 'katharina.seidensaal@med.uni-heidelberg.de', 'phone': '+496221', 'phoneExt': '8201'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Princip Investigator', 'investigatorFullName': 'Juergen Debus', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}