Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT01820858
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2013-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial 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': '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': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2013-03-20', 'studyFirstSubmitQcDate': '2013-03-26', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': '3-year DFS'}], 'secondaryOutcomes': [{'measure': 'Side effect of adjuvant chemotherapy', 'timeFrame': '3-month，6-month，1-year and 3-year', 'description': 'The incidence of infusion reactions (i.e.,skin reactions, cardiovascular reactions, respiratory or throat tightness), and allergic reactions (i.e., life-threatening anaphylaxis)'}, {'measure': 'Complications of radiotherapy', 'timeFrame': '3-month，6-month，1-year and 3-year', 'description': 'To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis.'}, {'measure': 'Quality of Life', 'timeFrame': '3-month，6-month，1-year and 3-year'}, {'measure': 'Overall survival (OS)', 'timeFrame': '3-year OS'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Endometrial Neoplasms']}, 'descriptionModule': {'briefSummary': 'This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* FIGO stage: Ⅰ, endometrial carcinoma;\n* Female, Chinese women;\n* Initial treatment is staging surgery;\n* Pathological diagnosis: Endometrial adenocarcinoma;\n* Pathologic examination and meet the following one of the indications of adjuvant therapy: ① histopathological grading in poorly differentiated: G3; ② ≥50% myometrial invasion; ③ vascular space involvement;\n* No prior treatment;\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;\n* Family history of ovarian cancer;\n* Suffering from other malignancies;\n* Concurrently participating in other clinical trials;\n* Unable or unwilling to sign informed consents;\n* Unable or unwilling to abide by protocol.'}, 'identificationModule': {'nctId': 'NCT01820858', 'acronym': 'EC-01', 'briefTitle': 'The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma', 'orgStudyIdInfo': {'id': '2012-GYN/EC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adjuvant Chemotherapy', 'description': 'Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.', 'interventionNames': ['Drug: Paclitaxel', 'Drug: Paraplatin (Carboplatin Injection)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adjuvant Radiotherapy', 'description': '1. Histopathological grade G3 and \\<50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times;\n2. Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy;\n3. ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times.', 'interventionNames': ['Radiation: Pelvic Radiation', 'Radiation: Vaginal Brachytherapy 1', 'Radiation: Vaginal brachytherapy 2']}], 'interventions': [{'name': 'Paclitaxel', 'type': 'DRUG', 'description': '175 mg/m(2), intravenously (IV)', 'armGroupLabels': ['Adjuvant Chemotherapy']}, {'name': 'Paraplatin (Carboplatin Injection)', 'type': 'DRUG', 'description': 'AUC=5, IV', 'armGroupLabels': ['Adjuvant Chemotherapy']}, {'name': 'Pelvic Radiation', 'type': 'RADIATION', 'description': '45-50 Gy', 'armGroupLabels': ['Adjuvant Radiotherapy']}, {'name': 'Vaginal Brachytherapy 1', 'type': 'RADIATION', 'description': '5 Gy, 3 times', 'armGroupLabels': ['Adjuvant Radiotherapy']}, {'name': 'Vaginal brachytherapy 2', 'type': 'RADIATION', 'description': '5 Gy, 2-4 times', 'armGroupLabels': ['Adjuvant Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital，Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Women's Hospital, School of Medicine, Zhejiang University", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Beihua Kong, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Qilu Hospital, Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ding Ma', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shandong University', 'class': 'OTHER'}, {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of the department of Obstetrics and Gynecology, Tongji Hospital', 'investigatorFullName': 'Ding Ma', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}