Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-13 @ 3:24 AM
Study NCT ID:
NCT05423704
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-06-21
First Post:
2022-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group feasibility study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2026-05-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-15', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2022-06-15', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dysphagia >= grade 2', 'timeFrame': 'Six months after end of radiotherapy', 'description': 'The rate of observer-reported dysphagia \\>= grade 2 measured by the DAHANCA late toxicity score (grade 0-4, with 0 being best)'}, {'measure': 'Xerostomia = grade 2', 'timeFrame': 'Six months after end of radiotherapy', 'description': 'The rate of patient-reported xerostomia measured by the EORTC Quality of life questionnaire (QLQ) Head-Neck (HN) 35 (grade 1-4, with 1 being best)'}], 'secondaryOutcomes': [{'measure': 'Loco-regional tumor control', 'timeFrame': 'Up to five years after end of radiotherapy', 'description': 'Time to event of local-regional failure, from date of randomization to the date of first documented loco-regional failure.\n\nRates are estimated by the Kaplan-Meier method. Interim analyses after 100, 200 and 300 patients. Will not be reported before the primary endpoint.'}, {'measure': 'Overall survival', 'timeFrame': 'Up to five years after end of radiotherapy]', 'description': 'From date of randomisation to date of death'}, {'measure': 'Acute toxicity', 'timeFrame': 'From the beginning of and up to two months after end of radiotherapy]', 'description': 'DAHANCA acute toxicity score (grade 0-4, 0 being best)'}, {'measure': 'Late toxicity', 'timeFrame': 'From two months to five years after end of radiotherapy]', 'description': 'DAHANCA late toxicity score (grade 0-4, 0 being best)'}, {'measure': 'EORTC QLQ-Head-Neck 35', 'timeFrame': 'Up to five years after end of radiotherapy', 'description': 'Swallowing and social-eating scale and specific HN35 items related to eating and pain (grade 1-4, 1 being best)'}, {'measure': 'EORTC C30', 'timeFrame': 'Up to five years after end of radiotherapy]', 'description': 'Specific C30 items related to fatigue, nausea and vomiting (grade 1-4, 1 being best)'}, {'measure': 'Time from referral to treatment', 'timeFrame': 'From date of referral to proton treatment to first proton treatment (Assessed up to 60 days)', 'description': 'Time from referral to proton center to first proton treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Proton radiotherapy'], 'conditions': ['Head-and-neck Cancer']}, 'descriptionModule': {'briefSummary': 'A study to investigate feasibility of local selection of patients with squamous cell carcinoma of the pharynx or larynx using anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia.', 'detailedDescription': 'In preparation for a randomised study in Denmark (DAHANCA 35) the feasibility of selecting newly diagnosed patients with squamous cell carcinoma of the pharynx or larynx for proton therapy at the local treatment centers is investigated. A proton and a photon doseplan is prepared for patients planned for primary radiotherapy . If proton radiotherapy reduces the anticipated absolute risk of dysphagia \\>= grade 2 (DAHANCA scale and/or xerostomia \\>= grade 2 (EORTC Head-Neck 35) with a clinical relevant value the patient is offered proton therapy at the Danish Center for Particle Therapy. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP).\n\nAt least five patients from each of the six Danish centers are required in this feasibility study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy with curative intent\n\nA predicted clinical significant reduction in the risk of any of the two primary endpoints (\\>= grade 2 observer-rated dysphagia or grade 2 patient-reported xerostomia) after proton therapy compared to photon therapy based on comparison of the individual patient dose plans\n\nNo current or earlier malignancies, which may influence treatment, evaluation or outcome of the head-neck cancer\n\nInformed consent as required by law\n\nAbove 18 years of age\n\nExclusion Criteria:\n\nPatient with cancers of the glottic larynx (stage I/II), skull base, sino-nasal area, nasopharynx, unknown primary tumor and prior malignancies.\n\nPatients with contraindications for proton therapy (as per 2019 pacemakers, implanted defibrillators and tracheostomy)\n\nInability to attend full course of radiotherapy or follow-up visits in the outpatient clinic\n\nDistant metastasis\n\nPrevious radiotherapy of the head and neck\n\nPrevious surgery for the primary cancer with curative intent'}, 'identificationModule': {'nctId': 'NCT05423704', 'briefTitle': 'Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark', 'organization': {'class': 'NETWORK', 'fullName': 'Danish Head and Neck Cancer Group'}, 'officialTitle': 'DAHANCA Proton Feasibility Study', 'orgStudyIdInfo': {'id': 'DAHANCA proton feasibility'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proton radiotherapy', 'description': 'Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA). Treatment: 66-68 Gy/ 33-34 fx/ 6/W,with cisplatin 40 mg/m2/W and nimorazole to suitable patients', 'interventionNames': ['Other: Proton radiotherapy']}], 'interventions': [{'name': 'Proton radiotherapy', 'type': 'OTHER', 'description': 'Proton radiotherapy according to the guidelines defined by the Danish Head-Neck Cancer Group (DAHANCA). Treatment: 66-68 Gy/ 33-34 fx/ 6/W, with cisplatin 40 mg/m2/W and nimorazole to suitable patients', 'armGroupLabels': ['Proton radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Danish Center for Particle Therapy', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'city': 'Næstved', 'country': 'Denmark', 'facility': 'Næstved Hospital', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Jeppe Friborg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Head-Neck Cancer Group (DAHANCA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Head and Neck Cancer Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}