Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT05551767
Status:
UNKNOWN
Last Update Posted:
2022-09-23
First Post:
2022-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-21', 'studyFirstSubmitDate': '2022-09-16', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response rate', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'rate of patients with no residual tumor after induction therapy including chemotherapy and radiotherapy'}, {'measure': 'progression-free survival', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Time from start of treatment to radiological disease progression'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'Time from start of treatment to death from any case'}, {'measure': 'objective response rate', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'response rate by RESCIST 1.1'}, {'measure': 'Organ-preserving treatment rate', 'timeFrame': 'through study completion, an average of 3 years', 'description': 'rate of patients with organ sparing treatment'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Cancer']}, 'descriptionModule': {'briefSummary': 'patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS\\>1 will recieve 3 cycles of induction immunochemotherapy with platinum, 5-FU and pembrolizumab followed by (chemo)radiation.', 'detailedDescription': 'patients with locally advanced cancer of oropharynx, hypopharynx or larynx and CPS\\>1 will recieve 3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation. Effect of induction therapy will be assesed by PET/CT and by endoscopic evaluation with biopsy of suspected residual tumor. Managemant of any residual tumor will be performed according with local rules and standards.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Squamous cell cancer of oropharynx (p16+: T0-3N3, T4N0-3, p16- : T3-4aN0-1, T1-4aN2-3), hypopharynx (T2-3N0-3, T1N+, T4aN0-3) or larynx III-IVa (T1-2N2-3, T3N2-3, T4aN0-3) , TNM8 staging classification;\n* Tumor is morphlogically confirmed;\n* CPS\\>1 (22C3 clone);\n* ECOG 0-2;\n* Age above 18 years;\n* Signed Informed consent form.\n\nExclusion Criteria:\n\n* Cancer of nasopharynx;\n* Non-squamous cell carcimomas or absense of morphological confirmation of squamous cell cancer;\n* Stages I or II;\n* ECOG\\>=3.'}, 'identificationModule': {'nctId': 'NCT05551767', 'briefTitle': 'Induction Immunochemotherapy in Stage III-IVa Head and Neck Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'City Clinical Oncology Hospital No 1'}, 'officialTitle': 'Induction Immunochemotherapy in Stage III-IVa Cancer of Oropharynx, Hypopharynx and Larynx', 'orgStudyIdInfo': {'id': 'HN01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': '3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg) followed by (chemo)radiation. Effect of induction therapy will be assesed by PET/CT and by endoscopic evaluation with biopsy of suspected residual tumor. Managemant of any residual tumor will be performed according with local rules and standards.', 'interventionNames': ['Drug: Pembrolizumab']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'DRUG', 'otherNames': ['cisplatin and 5-FU'], 'description': '3 cycles of induction immunochemotherapy with platinum (cisplatin 75 mg\\\\m2, 5-FU 1000 mg/m2/day 96-hour infusion and pembrolizumab 200 mg)', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111123', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Ludmila G Zhukova', 'role': 'CONTACT'}], 'facility': 'Moscow Clinical Scientific Center named after Loginov', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129090', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Ilya A Pokataev', 'role': 'CONTACT', 'email': 'pokia@mail.ru', 'phone': '+79262858986'}], 'facility': 'City clinical oncology hospital 1', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '143423', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Daniil L Stroyakovsky', 'role': 'CONTACT'}], 'facility': 'Moscow City Oncology Hospital No 62', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Ilya А Pokataev', 'role': 'CONTACT', 'email': 'pokia@mail.ru', 'phone': '+79262858986'}, {'name': 'Olesya Stativko', 'role': 'CONTACT', 'email': 'olesya_stativko@mail.ru', 'phone': '+79061522724'}], 'overallOfficials': [{'name': 'Vsevolod N Galkin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City Clinical Oncology Hospital No 1'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City Clinical Oncology Hospital No 1', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Moscow City Oncology Hospital No. 62', 'class': 'OTHER_GOV'}, {'name': 'Moscow Clinical Scientific Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}