Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 8:19 AM
Study NCT ID:
NCT03955367
Status:
UNKNOWN
Last Update Posted:
2022-02-23
First Post:
2019-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic RT Versus Prophylactic Extended-field RT in Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 638}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-06', 'studyFirstSubmitDate': '2019-05-11', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '3-year', 'description': 'Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3-year', 'description': 'Overall survival is calculated from randomization to death from any cause.'}, {'measure': 'Distant failure-free survival', 'timeFrame': '3-year', 'description': 'Distant failure-free survival is defined as the time from randomization to distant metastasis or death from any cause, whichever is first.'}, {'measure': 'Para-aortic lymph nodes failure rate', 'timeFrame': '3-year', 'description': 'The incidence of para-aortic lymph nodes failure.'}, {'measure': 'Acute toxicity evaluated with CTCAE 5.0', 'timeFrame': 'From the start of treatment to 3 months after treatment.', 'description': 'Evaluated with CTCAE 5.0'}, {'measure': 'Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme', 'timeFrame': '3-year', 'description': 'Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uterine Cervical Neoplasms', 'Extended-field irradiation'], 'conditions': ['Uterine Cervical Neoplasms']}, 'referencesModule': {'references': [{'pmid': '30153215', 'type': 'BACKGROUND', 'citation': 'Wang W, Liu X, Meng Q, Zhang F, Hu K. Prophylactic Extended-Field Irradiation for Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy: A Propensity-Score Matching Analysis. Int J Gynecol Cancer. 2018 Oct;28(8):1584-1591. doi: 10.1097/IGC.0000000000001344.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the value of prophylactic extended-field irradiation (EFI), we conduct a randomized clinical trial to compare the efficacy and toxicity of pelvic irradiation and prophylactic EFI in selected patients with cervical cancer treated with definitive concurrent chemoradiotherapy. External beam radiation therapy is delivered with intensity-modulated radiation therapy (IMRT).', 'detailedDescription': 'This is a multicenter, open-label, phase III randomized clinical trial. Cervical cancer patients without evidence of para-aortic metastatic lymph nodes (MLNs) and with at least one of the following characteristics are included in the present study: (a) Number of pelvic MLNs ≥ 2; (b)Short diameter of pelvic MLNs ≥ 1.5cm; (c)Pelvic wall involvement. Patients are randomly assigned to pelvic irradiation group and prophylactic EFI group. Patients in pelvic irradiation group receive pelvic irradiation, intracavitary brachytherapy and concurrent chemotherapy. Patients in prophylactic EFI group receive irradiation for pelvis and para-aortic lymph nodes region, intracavitary brachytherapy and concurrent chemotherapy. The upper border of clinical target volume (CTV) is at the level of renal vessels for patients in prophylactic EFI group. A dose of 45-50.4 Gy is delivered to CTV with IMRT in both groups. Patients receive cisplatin based concurrent chemotherapy (single cisplatin or cisplatin plus paclitaxel). The primary endpoint is progression-free survival.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be informed of the investigational nature of this study and give written informed consent with 30 days before treatment.\n2. Age ≥18 years and ≤ 70 years.\n3. Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.\n4. No evidence of para-aortic metastatic lymph nodes (MLNs) on CT, MRI or positron emission tomograph (PET)/CT.\\*\n5. No evidence of distant metastasis (FIGO stage IVB).\n6. At least meet one of the following characteristics:\n\n 1. Number of pelvic MLNs ≥ 2;\n 2. Short diameter of pelvic MLNs ≥ 1.5cm; \\*\n 3. Parametrial involvement to the pelvic wall ＃.\n7. Satisfactory performance: Eastern Cooperative Oncology Group (ECOG) score ≥ 2.\n8. Adequate marrow: neutrophile granulocyte count ≥1.5\\*10\\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\\*10\\^9/L.\n9. Normal liver and kidney function: Creatinine (Cr) \\< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \\< 2\\*upper limit of normal (ULN).\n\n * MLNs refer to positive lymph nodes confirmed by PET/CT or lymph nodes with short diameter ≥ 1 cm on CT or MRI.\n\n * Parametrial involvement to the pelvic wall is diagnosed with gynecological examination or MRI;\n\nExclusion Criteria:\n\n1. With common iliac MLNs.\n2. Tumor extended to the lower third of the vagina.\n3. Tumor spread to mucosa of the bladder or rectum.\n4. Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.\n5. Prior malignancy.\n6. History of previous radiotherapy to the abdomen or pelvis.\n7. Pregnancy or lactation.\n8. Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.\n9. Active infection with fever.\n10. Patients with unacceptable risk that intracavitary brachytherapy can not be conducted.\n11. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.'}, 'identificationModule': {'nctId': 'NCT03955367', 'briefTitle': 'Pelvic RT Versus Prophylactic Extended-field RT in Patients With Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Pelvic Irradiation Versus Prophylactic Extended-field Irradiation in Selected Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy: A Multicenter, Open-label, Randomized, Phase 3 Trial', 'orgStudyIdInfo': {'id': 'PUMCH-EFI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pelvic Irradiation', 'description': 'Patients receive concurrent chemoradiotherapy. The CTV includes the gross tumor, cervix, uterus, parametrium, upper part of the vagina, and pelvic lymph nodes regions. The upper border of CTV is at the level of aortic bifurcation. A dose of 45-50.4Gy is delivered to CTV with IMRT.', 'interventionNames': ['Radiation: Pelvic irradiation', 'Radiation: Intracavitary brachytherapy', 'Drug: Concurrent chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Prophylactic EFI', 'description': 'Patients receive concurrent chemoradiotherapy. The CTV includes the gross tumor, cervix, uterus, parametrium, upper part of the vagina, pelvic lymph nodes regions and para-aortic lymph nodes region. The upper border of CTV is at the level of renal vessels. A dose of 45-50.4Gy is delivered to CTV with IMRT.', 'interventionNames': ['Radiation: Prophylactic extended-field Irradiation', 'Radiation: Intracavitary brachytherapy', 'Drug: Concurrent chemotherapy']}], 'interventions': [{'name': 'Prophylactic extended-field Irradiation', 'type': 'RADIATION', 'otherNames': ['Prophylactic radiotherapy for para-aortic lymph nodes region'], 'description': 'CTV covers pelvis and para-aortic lymph nodes region.', 'armGroupLabels': ['Prophylactic EFI']}, {'name': 'Pelvic irradiation', 'type': 'RADIATION', 'otherNames': ['Pelvic radiotherapy'], 'description': 'CTV covers pelvis.', 'armGroupLabels': ['Pelvic Irradiation']}, {'name': 'Intracavitary brachytherapy', 'type': 'RADIATION', 'otherNames': ['Brachytherapy'], 'description': 'The total dose delivered to point A or high-risk CTV is ≥80Gy. For patients with larger-volume cervical tumor, the total dose is ≥85Gy.', 'armGroupLabels': ['Pelvic Irradiation', 'Prophylactic EFI']}, {'name': 'Concurrent chemotherapy', 'type': 'DRUG', 'otherNames': ['Chemotherapy'], 'description': 'Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.', 'armGroupLabels': ['Pelvic Irradiation', 'Prophylactic EFI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ke Hu, MD', 'role': 'CONTACT', 'email': 'huk@pumch.cn', 'phone': '010-69155482'}, {'name': 'Weiping Wang, PhD', 'role': 'CONTACT', 'email': 'jluwangweiping@163.com', 'phone': '010-69155483'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zi Liu', 'role': 'CONTACT'}], 'facility': "First Affiliated Hospital Xi'an Jiaotong University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}], 'centralContacts': [{'name': 'Ke Hu', 'role': 'CONTACT', 'email': 'huk@pumch.cn', 'phone': '+86-01069155487'}], 'overallOfficials': [{'name': 'Ke Hu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'Cangzhou Central Hospital', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, {'name': 'Gansu Wuwei Tumor Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Harbin Medical University Third Affiliated Hospital', 'class': 'OTHER'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, {'name': "Guizhou Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'China-Japan Union Hospital, Jilin University', 'class': 'OTHER'}, {'name': 'Jilin Provincial Tumor Hospital', 'class': 'OTHER'}, {'name': 'Jiangsu Cancer Institute & Hospital', 'class': 'OTHER'}, {'name': "940 Hospital of the People's Liberation Army Joint Logistic Support Force", 'class': 'OTHER'}, {'name': 'General Hospital of Benxi Iron & Steel Industry Group', 'class': 'UNKNOWN'}, {'name': 'The Affiliated Hospital of Inner Mongolia Medical University', 'class': 'OTHER'}, {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, {'name': 'Beijing Obstetrics and Gynecology Hospital', 'class': 'OTHER'}, {'name': "Tangshan People's Hospital", 'class': 'OTHER'}, {'name': 'Zhongnan Hospital', 'class': 'OTHER'}, {'name': "Second Affiliated Hospital of Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': 'The Affiliated Tumor Hospital of Xinjiang Medical University', 'class': 'UNKNOWN'}, {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'Affiliated Cancer Hospital of Zhengzhou University', 'class': 'UNKNOWN'}, {'name': 'Seventh Medical Center of PLA Army General Hospital', 'class': 'OTHER'}, {'name': 'Shengjing Hospital', 'class': 'OTHER'}, {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, {'name': "Xi'an Gaoxin Hospital", 'class': 'OTHER'}, {'name': 'West China Second University Hospital', 'class': 'OTHER'}, {'name': 'The Forth Affiliated Hospital of Guangxi Medical University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice director of Radiation Oncology Department', 'investigatorFullName': 'Ke Hu', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}