Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
Study NCT ID:
NCT04214366
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2019-09-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003528', 'term': 'Carcinoma, Adenoid Cystic'}, {'id': 'D012468', 'term': 'Salivary Gland Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-01', 'size': 662857, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-27T13:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 314}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2032-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2019-12-27', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from loco-regional progression', 'timeFrame': 'at 5 years', 'description': 'Freedom from loco-regional tumor progression according to MR imaging'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'at 3 and 5 years', 'description': 'Progression-free survival'}, {'measure': 'Overall survival', 'timeFrame': 'at 3 and 5 years', 'description': 'Overall survival'}, {'measure': 'Acute toxicities', 'timeFrame': 'during and up to 6 weeks after radiotherapy', 'description': 'Acute toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity \\> 2 grade)'}, {'measure': 'Late toxicities', 'timeFrame': 'up to 5 years', 'description': 'Late toxicities according to NCI CTC AE (Version 5.0) (rate of toxicity \\> 2 grade)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carbon ion', 'heavy ion', 'salivary gland tumor', 'ACC', 'Radiation therapy'], 'conditions': ['Adenoid Cystic Carcinoma']}, 'referencesModule': {'references': [{'pmid': '34266402', 'type': 'DERIVED', 'citation': 'Lang K, Adeberg S, Harrabi S, Held T, Kieser M, Debus J, Herfarth K. Adenoid cystic Carcinoma and Carbon ion Only irradiation (ACCO): Study protocol for a prospective, open, randomized, two-armed, phase II study. BMC Cancer. 2021 Jul 15;21(1):812. doi: 10.1186/s12885-021-08473-5.'}]}, 'descriptionModule': {'briefSummary': 'Adenoid cystic tumors are rare tumors of the head and neck region. Despite their slow growth, re-irradiation is often necessary due to the high metastatic risk. Patients are usually irradiated with photons or, as here at the Heidelberg University Hospital, with a combination of carbon ions and photons. So far, there is no data from Europe available for the sole irradiation with carbon ions. The present ACCO (Adenoid Cystic Carcinoma and Carbon ion Only irradiation) study, a prospective, open-label, phase II, single-arm, investigator-initiated study, will therefore investigate the sole radiotherapy of carbon ions in this tumor entity. Irradiation is applied - significantly shorter than the combination therapy - in about 4 weeks (22 fractions); patients are followed up for further 5 years after the start of therapy. Carbon ions alone are expected to increase local tumor control rates from 60% to 70% after 5 years (primary objective criterion of this study). In order to reject the null hypothesis with a power of 80% and a significance level of 5%, 175 patients are included (including a drop-out rate of 15%). Secondary objective criteria are progression-free survival, overall survival, acute and late toxicity, and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenoid cystic carcinoma in the head and neck area\n* Indication for irradiation:\n* non-operable or\n* R1/R2 resected or\n* perineural sheat invasion (Pn+) or\n* pT3/pT4\n* Informed consent\n* KI \\> 60% or ECOG 0/1 (minimum: self-sufficiency, normal activity or work not possible)\n* Age 18-80 years\n\nExclusion Criteria:\n\n* rejection of the study by the patient\n* Patient is not able to consent\n* Stage IV (distant metastases), except lung metastases \\< 1cm\n* lymph node involvement (clinical or pathological)\n* Previous radiotherapy in the head and neck area\n* Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)\n* Contraindication to MR imaging\n* Simultaneous participation in another clinical study that could influence the outcome of this study or the other study\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04214366', 'acronym': 'ACCO', 'briefTitle': 'Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation', 'orgStudyIdInfo': {'id': 'ACCO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carbon Ion irradiation', 'description': '22 x 3 Gy(RBE) Carbon Ions', 'interventionNames': ['Radiation: Carbon ion irradiation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bimodal Arm', 'description': '25 x 2 Gy photon IMRT and 8 x 3 Gy(RBE) Carbon ion boost', 'interventionNames': ['Radiation: Bimodal irradiation']}], 'interventions': [{'name': 'Carbon ion irradiation', 'type': 'RADIATION', 'description': '22 x 3 Gy(RBE) Carbon Ions', 'armGroupLabels': ['Carbon Ion irradiation']}, {'name': 'Bimodal irradiation', 'type': 'RADIATION', 'description': '25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost', 'armGroupLabels': ['Bimodal Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Klaus Herfarth, Prof. Dr.', 'role': 'CONTACT', 'email': 'klausherfarth@med.uni-heidelberg.de', 'phone': '+49 6221 568201'}, {'name': 'Klaus Herfarth, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Heidelberg, Radiooncology, HIT', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Klaus Herfarth, Prof. Dr.', 'role': 'CONTACT', 'email': 'klaus.herfarth@med.uni-heidelberg.de', 'phone': '+49 6221 56 8201'}], 'overallOfficials': [{'name': 'Klaus Herfarth, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Heidelberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Klaus Herfarth, Vice chair Dept. of Radiation Oncology', 'investigatorFullName': 'Klaus Herfarth, MD', 'investigatorAffiliation': 'Heidelberg University'}}}}