Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-19 @ 6:58 PM
Study NCT ID:
NCT04194268
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-20
First Post:
2019-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreatic Cancer and Carbon Ion Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2019-12-09', 'studyFirstSubmitQcDate': '2019-12-09', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival', 'timeFrame': '12 month after radiation', 'description': 'overall survival'}], 'secondaryOutcomes': [{'measure': 'toxicity outcomes', 'timeFrame': '48 Month after radiatoin', 'description': 'Incidence of grade 3/4 NCI-CTC-AE toxicity'}, {'measure': 'survival', 'timeFrame': '12 month after radiation', 'description': 'Progression free survival'}, {'measure': 'Blood Parameters Ca 19-9', 'timeFrame': '48 Month after radiation', 'description': 'Change in Ca 19-9'}, {'measure': 'Blood Parameters CEA', 'timeFrame': '48 Month after radiation', 'description': 'Change in CEA levels'}, {'measure': 'Quality of life (QLQ) EORTC QLQ C30', 'timeFrame': '48 Month after radiation', 'description': 'Change on scoring on EORTC QLQ C30'}, {'measure': 'Quality of life EORTC QLQ Pan26', 'timeFrame': '48 Month after radiation', 'description': 'Change on scoring EORTC QLQ Pan26'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '33004046', 'type': 'DERIVED', 'citation': 'Liermann J, Naumann P, Hommertgen A, Pohl M, Kieser M, Debus J, Herfarth K. Carbon ion radiotherapy as definitive treatment in non-metastasized pancreatic cancer: study protocol of the prospective phase II PACK-study. BMC Cancer. 2020 Oct 1;20(1):947. doi: 10.1186/s12885-020-07434-8.'}]}, 'descriptionModule': {'briefSummary': 'Irradiation of non-operable pancreatic cancer with carbon ions (C12). This therapy is expected to be more effective than the current Gold Standard of photon irradiation applied in the case of non-operable pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed, inoperable primary or local recurrent pancreatic cancer\n* Written informed consent (must be available before enrollment in the trial)\n* Karnofsky performance score \\> 60 or ECOG-status 0/1 (at least: patient should be able to take care of himself, although daily-life activity or work is not possible)\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* No clear difference between tumor edge and upper gastrointestinal tract in baseline imaging\n* Extensive lymphatic metastases\n* Disability of subject to understand character and individual consequences of the clinical trial\n* Distant metastases\n* Previous radiotherapy of the upper abdomen\n* Active medical implants (e.g. pacemaker, defibrillator), contradicting radiotherapy at HIT\n* Participation in another clinical study or observation period of competing trials, respectively'}, 'identificationModule': {'nctId': 'NCT04194268', 'acronym': 'PACK', 'briefTitle': 'Pancreatic Cancer and Carbon Ion Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Pancreatic Cancer and Carbon Ion Radiotherapy', 'orgStudyIdInfo': {'id': 'RADONK-PACK-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional arm', 'description': 'Carbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks', 'interventionNames': ['Radiation: Carbon Ion']}], 'interventions': [{'name': 'Carbon Ion', 'type': 'RADIATION', 'description': '12 x 4 Gy (RBE)', 'armGroupLabels': ['Interventional arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University Hopsital Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department', 'investigatorFullName': 'Juergen Debus', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}