Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT04012502
Status:
UNKNOWN
Last Update Posted:
2019-07-09
First Post:
2019-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 83}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2019-07-04', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '2 year', 'description': 'Progression Free Survival'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': '2 year', 'description': 'Overall Survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oropharyngeal Carcinoma', 'De-escalation']}, 'descriptionModule': {'briefSummary': 'Human papillomavirus (HPV)-related oropharyngeal carcinoma are exquisitely radiosensitive. Several studies attempted to reduce the toxicities of treatments through reduced-dose radiation and showed promising results, but all data were collected from non-Chinese areas. Like nasopharyngeal carcinoma, oropharyngeal carcinoma may have different biological behavior and relationship with HPV infection. So the investigators studied whether toxicities reducing treatment with reduced radiation dose and omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with HPV-positive oropharyngeal carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of squamous cell carcinoma of oropharynx with IHC p16 positive or PCR HPV16 positive\n* T1-2/N1-3M0（except T1N1M0 and single LN\\<3cm）or T3-4N0-3M0 according to UICC/AJCC 8th staging system\n* Age ≥18\n* No prior anti-tumor treatment\n* Karnofsky Performance Score (KPS)≥70\n* Adequate blood supply\n* Informed consent obtained\n\nExclusion Criteria:\n\n* cannot take contrast-MRI imaging\n* Pregnant\n* Combined with other malignant tumor (except basal cell carcinoma of skin)'}, 'identificationModule': {'nctId': 'NCT04012502', 'briefTitle': 'De-escalation Protocols in HPV-related Oropharyngeal Carcinoma in Chinese Populations', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'De-escalation of Chemoradiotherapy Density in HPV-related Oropharyngeal Carcinoma in Chinese Populations', 'orgStudyIdInfo': {'id': '2019-OR001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional treatment arm', 'description': 'Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)', 'interventionNames': ['Other: conventional treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Toxicities reduced treatment arm', 'description': 'Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)', 'interventionNames': ['Other: Toxicities reduced treatment']}], 'interventions': [{'name': 'Toxicities reduced treatment', 'type': 'OTHER', 'description': 'Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)', 'armGroupLabels': ['Toxicities reduced treatment arm']}, {'name': 'conventional treatment', 'type': 'OTHER', 'description': 'Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)', 'armGroupLabels': ['conventional treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tingting Xu, MD', 'role': 'CONTACT', 'email': 'dr_tingtingxu@163.com', 'phone': '+8618017312903'}, {'name': 'Xueguan Lu, MD', 'role': 'CONTACT', 'email': 'luxueguan@163.com', 'phone': '+8618121299382'}], 'facility': 'Fudan Universtiy Shanghai Cancer Centre', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Tingting xu, MD', 'role': 'CONTACT', 'email': 'dr_tingtingxu@163.com', 'phone': '+8618017312903'}, {'name': 'xueguan Lu, MD', 'role': 'CONTACT', 'email': 'luxueguan@163.com', 'phone': '+8618121299382'}], 'overallOfficials': [{'name': 'Chaosu Hu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University Shanghai cancer centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chaosu Hu', 'investigatorAffiliation': 'Fudan University'}}}}