Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-24 @ 4:42 PM
Study NCT ID:
NCT06562166
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2024-08-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Online Adaptive Radiotherapy for Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-23', 'studyFirstSubmitDate': '2024-08-16', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute non-hematological toxicity', 'timeFrame': 'From the start of treatment until 3 months later', 'description': 'Acute non-hematologic toxicities include gastrointestinal and genitourinary toxicities, which will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.'}], 'secondaryOutcomes': [{'measure': 'treatment response', 'timeFrame': '3 months after completion of treatment', 'description': 'Treatment response will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical cancer', 'adaptive radiotherapy'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the clinical efficacy and safety of online adaptive radiotherapy for cervical cancer patients received radical radiotherapy. By comparing with image-guided radiotherapy, the study explores the potential advantages of online adaptive radiotherapy in reducing treatment toxicity and improving local control.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-70 years old;\n2. Pathologically confirmed diagnosis of cervical cancer and pathological type of cervical squamous carcinoma;\n3. 2018 FIGO Stage Ib3, II, and IIIC1\n4. Proposed radical pelvic radiotherapy + concurrent sensitizing chemotherapy (platinum-based (cisplatin 30-40mg/m2 or carboplatin alone), starting concurrently in the first week, ≥5 courses)\n5. ECOG score 0-2\n6. Life expectancy greater than 6 months\n7. Ability to remain lying down for more than 30 minutes\n8. Patients were fully voluntary and autonomous and co-operated in signing the study informed consent form\n9. Complete blood count and basal metabolic indexes within 14 days before enrolment must meet the following requirements: NEUT ≥ 1.5\\*109/L, HGB ≥ 60g/L, platelets ≥ 100×109/, blood creatinine \\<1.5 mg/dL. AST and ALT are within 2 times the upper limit of normal\n10. Must complete baseline assessments and investigations required before treatment before enrolment\n11. be eligible for regular follow-up\n\nExclusion Criteria:\n\n1. Have received radiotherapy or chemotherapy in the past\n2. Have undergone radical surgery for cervical cancer\n3. Have a previous history of malignant tumor\n4. Pregnant or lactating women\n5. Presence of other serious co-morbidities such as poorly controlled cardiovascular, urinary, digestive, respiratory, hematological and central nervous system diseases.'}, 'identificationModule': {'nctId': 'NCT06562166', 'briefTitle': 'Online Adaptive Radiotherapy for Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Online Adaptive Radiotherapy (oART) in Radical Radiotherapy for Cervical Cancer - a Multi-center Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'ART_cervical cancer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ART', 'interventionNames': ['Radiation: online adaptive radiotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'IGRT'}], 'interventions': [{'name': 'online adaptive radiotherapy', 'type': 'RADIATION', 'description': 'Patients in ART group received daily online adaptive radiotherapy with a prescription dose of 50.4Gy/28f.', 'armGroupLabels': ['ART']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuai Sun', 'role': 'CONTACT', 'email': 'drsunshuai@163.com', 'phone': '+86-15540101705'}], 'facility': 'Peking union medical college hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shuai Sun', 'role': 'CONTACT', 'email': 'sunshuai@pumch.cn', 'phone': '15801390180'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Jiangsu University', 'class': 'UNKNOWN'}, {'name': 'Zhongnan Hospital', 'class': 'OTHER'}, {'name': "Jingzhou First People's Hospital", 'class': 'UNKNOWN'}, {'name': 'The First Affiliated Hospital of Nanhua University', 'class': 'UNKNOWN'}, {'name': 'Tongji Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}