Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-30 @ 6:22 PM
Study NCT ID:
NCT06947668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tumour tissue; stool sample; blood samples; saliva samples (mucosal swabs)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2025-04-20', 'studyFirstSubmitQcDate': '2025-04-25', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Identification of the point in time when immunotherapy should be used', 'timeFrame': '61 months (duration of entire trial)'}], 'primaryOutcomes': [{'measure': 'Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype', 'timeFrame': '61 months (duration of entire trial)'}], 'secondaryOutcomes': [{'measure': 'Correlation of immunophenotype with overall survival, locoregional control and side effects', 'timeFrame': '61 months (duration of entire trial)'}, {'measure': 'Identification of immunological parameters associated with relevant treatment-related complications (e.g. infection, cytopenia)', 'timeFrame': '61 months (duration of entire trial)'}, {'measure': 'Identification of patients who will benefit from immunotherapy.', 'timeFrame': '61 months (duration of entire trial)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Squamous Cell Carcinoma of Oropharynx', 'Squamous Cell Carcinoma of the Hypopharynx', 'Larynx Squamous Cell Carcinoma', 'Oral Cavity Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': "Analysis of tumor tissue (which is already available in pathology) and collection of saliva/stool and blood samples, which are obtained as part of a routine collection. These will be evaluated together with the patients' clinical data to identify possible predictors for treatment feasibility, survival, tumor control and potentially increased tumor immunogenicity by docetaxel."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with squamous cell carcinoma of the head and neck without distant metastases, for whom definitive or postoperative chemoradiation is indicated and who are unfit for cisplatin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with squamous cell carcinomas of the oropharynx, larynx and oral cavity for whom definitive or postoperative chemoradiation is indicated\n* Patients who are cisplatin-unfit for chemotherapy, defined as:\n\n * ECOG 2\n * Organ dysfunction ≥ 2 according to National Cancer Institute Common Toxicity Criteria (NCI CTC) Version 4.0, such as hearing loss or tinnitus or neurological diseases\n * Calculated creatinine clearance of ≤50ml/min\n * Impaired organ function or comorbidities that preclude the use of cisplatin, e.g.: left ventricular ejection fraction \\< 50%, uncorrectable renal insufficiency with elevated creatinine despite creatinine clearance of 50ml/min due to increased body weight, uncontrolled hypertension\n * Poor nutritional status BMI \\< 16kg/m²\n * Concomitant use of nephrotoxic drugs that cannot be discontinued or converted due to other illnesses.\n * Willingness of patients to provide blood, saliva and stool samples and consent to the preservation of all samples for study purposes\n * Age ≥ 18 years\n * Sufficient cognitive abilities of the patients to understand the purpose of the study and to consent to it\n\nExclusion Criteria:\n\n* Distant metastases at the time of diagnosis and simultaneous second cancers, i.e. at the time of study inclusion\n* Malignancies in the last 5 years regardless of location (except basal cell carcinoma or cervical uteri)\n* Carcinomas in which no sample collection is possible or likely without compromising the pathological assessment\n* Persistent drug or medication abuse\n* Patients who are unwilling or unable to comply with the protocol and receive treatment\n* Patients who are unsuitable for participation in the study due to a language barrier'}, 'identificationModule': {'nctId': 'NCT06947668', 'acronym': 'DoIT_Neck', 'briefTitle': 'Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel', 'orgStudyIdInfo': {'id': 'DoIT_Neck'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment group', 'description': 'Patients with squamous cell carcinoma of the head and neck without distant metastases, for whom definitive or postoperative chemoradiation is indicated and who are unfit for cisplatin.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'contacts': [{'name': 'Studiensekretariat', 'role': 'CONTACT', 'email': 'studiensekretariat.ST@uk-erlangen.de', 'phone': '+49913185', 'phoneExt': '33968'}, {'name': 'Benjamin Frey, MD', 'role': 'CONTACT', 'email': 'benjamin.frey@uk-erlangen.de', 'phone': '+49913185', 'phoneExt': '44248'}, {'name': 'Marlen Haderlein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Charlotte Schmitter, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Phillip Schubert, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Erlangen, Strahlenklinik', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'centralContacts': [{'name': 'Marlen Haderlein, MD', 'role': 'CONTACT', 'email': 'marlen.haderlein@uk-erlangen.de', 'phone': '+49913185', 'phoneExt': '33968'}, {'name': 'Charlotte Schmitter, MD', 'role': 'CONTACT', 'email': 'charlotte.schmitter@uk-erlangen.de', 'phone': '+49913185', 'phoneExt': '33968'}], 'overallOfficials': [{'name': 'Marlen Haderlein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Erlangen, Strahlenklinik'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}