Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT04813705
Status:
RECRUITING
Last Update Posted:
2023-02-21
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056687', 'term': 'Off-Label Use'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D011307', 'term': 'Drug Prescriptions'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 93}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biomarkers', 'timeFrame': 'up to 5 years', 'description': 'The correlation between the radiotherapy dose with biomarkers such as peripheral blood lymphocyte and EBV-DNA.'}], 'primaryOutcomes': [{'measure': 'Local-regional recurrence free survival (LRFS)', 'timeFrame': '5 years', 'description': 'The LRFS is evaluated and calculated from the date of initiation of treatment until the day of first locoregional relapse or until the date of the last follow-up visit.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '5 years', 'description': 'The OS was defined as the duration from the date of of initiation of treatment to the date of death from any cause or censored at the date of the last follow-up.'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': '5 years', 'description': 'Progress-free survival is calculated from the date of initiation of treatment to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.'}, {'measure': 'Distant metastasis-free survival (DMFS)', 'timeFrame': '5 years', 'description': 'The DMFS is evaluated and calculated from the date of initiation treatment until the day of first distant metastases or until the date of the last follow-up visit.'}, {'measure': 'Incidence of treatment related acute complications', 'timeFrame': 'up to 3 months', 'description': 'treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.'}, {'measure': 'Incidence of treatment related late complications', 'timeFrame': 'up to 5 years', 'description': 'treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.'}, {'measure': 'Overall response rate', 'timeFrame': 'up to 5 years', 'description': 'efficacy will be measured by PERCIST1.0 and RECIST1.1 criteria.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore whether 18F-FDG PET/CT guided reduced-dose radiotherapy would maintain survival outcomes in nasopharyngeal carcinoma (NPC) patients.', 'detailedDescription': 'Enrolled patients with complete metabolic response (CMR) and more than 70% partial metabolic response (PMR) according to PERCIST criteria at the 25th fraction will receive intensity modulated radiation therapy (IMRT) of reduced-dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions), for those who with ≤70% PMR will receive conventional dose (prescribed dose, 70Gy, 2.12 Gy per fractions, 33 fractions).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathology confirmed nasopharyngeal squamous cell carcinoma.\n2. Stage I-IVA（8thAJCC/UICC staging system).\n3. Aged 18-80 years.\n4. KPS≥70.\n5. Have measurable lesions on 18F-FDG PET/CT before treatment.\n6. HGB≥90 g/L，ANC≥1.5×109 /L，PLT≥80×109 /L.\n7. ALT,AST\\<2.5 fold of ULN；TBIL\\<2.0×ULN.\n8. CCR≥60ml/min or Cr\\<1.5×ULN.\n9. Signed informed consent.\n10. Have follow up condition.\n\nExclusion Criteria:\n\n1. Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ).\n2. Age \\<18 or \\>80years.\n3. Pregnancy or lactation.\n4. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).\n5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.\n6. With sever infection and internal disease.\n7. Major organ dysfunction, such as decompensated cardiopulmonary, kidney, liver failure, cannot tolerate surgical treatment.'}, 'identificationModule': {'nctId': 'NCT04813705', 'briefTitle': '18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Taizhou Hospital'}, 'officialTitle': 'A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'PRR-202103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced dose group', 'description': 'The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.', 'interventionNames': ['Radiation: Reduced dose', 'Drug: Chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional dose group', 'description': 'The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.', 'interventionNames': ['Radiation: Conventional dose', 'Drug: Chemotherapy']}], 'interventions': [{'name': 'Reduced dose', 'type': 'RADIATION', 'description': 'The patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.', 'armGroupLabels': ['Reduced dose group']}, {'name': 'Conventional dose', 'type': 'RADIATION', 'description': 'The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.', 'armGroupLabels': ['Conventional dose group']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'The patients with stage II will receive concurrent cisplatin during Intensity modulated radiotherapy (IMRT), and stage III-IVA patients will receive platinum based induction chemotherapy every 21 days for at least two cycles followed by concurrent cisplatin during IMRT.', 'armGroupLabels': ['Conventional dose group', 'Reduced dose group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '317000', 'city': 'Taizhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shenpeng Ying', 'role': 'CONTACT', 'phone': '13957608158'}, {'name': 'Shenpeng Ying', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bo Wu', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Taizhou Central Hospital', 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}, {'zip': '317000', 'city': 'Taizhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haihua Yang, MD', 'role': 'CONTACT', 'email': 'yhh93181@hotmail.com', 'phone': '+86 13819639006'}, {'name': 'Weijun Ding', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jian Zhu', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Taizhou Hospital', 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}, {'zip': '317500', 'city': 'Taizhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangxian You, MD', 'role': 'CONTACT', 'phone': '13676668511'}, {'name': 'Guangxian You', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Linggang Zhu', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Taizhou Cancer Hospital', 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}, {'zip': '318050', 'city': 'Taizhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haihua Yang, MD', 'role': 'CONTACT', 'email': 'yhh93181@hotmail.com', 'phone': '+86 13819639006'}, {'name': 'Haihua Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiate Zhou, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Taizhou Enze Medical Center(Group) Enze Hospital', 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}], 'centralContacts': [{'name': 'Haihua Yang, MD', 'role': 'CONTACT', 'email': 'yhh93181@hotmail.com', 'phone': '13819639006'}], 'overallOfficials': [{'name': 'Haihua Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taizhou Enze Medical Center Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taizhou Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taizhou Enze Medical Center Group', 'class': 'OTHER'}, {'name': 'Taizhou Cancer Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Radiation Oncology', 'investigatorFullName': 'Haihua Yang', 'investigatorAffiliation': 'Taizhou Hospital'}}}}