Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-29 @ 11:32 PM
Study NCT ID:
NCT04453904
Status:
RECRUITING
Last Update Posted:
2020-07-01
First Post:
2020-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 654}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-28', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-06-28', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progress-free survival', 'timeFrame': 'From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 60 months', 'description': 'To determine if treatment with radiochemotherapy in "sanwich" mode (carboplatin and paclitaxel for 2 cycles, then radiotherapy, and then carboplatin and paclitaxel for 4 cycles)(experimental arm) reduces the rate of recurrence or death (i.e., increases disease-free survival) when compared to concurrent cisplatin and radiation followed by carboplatin and paclitaxel for 4 cycles (control arm) in patients with stages III endometrial adenocarcinoma.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From the date of randomization until the date of death from any cause, assessed up to 60 months', 'description': 'To determine if treatment with radiochemotherapy in "sanwich" mode (carboplatin and paclitaxel for 2 cycles, then radiotherapy, and then carboplatin and paclitaxel for 4 cycles)(experimental arm) reduces the rate of death (i.e., increases survival) when compared to concurrent cisplatin and radiation followed by carboplatin and paclitaxel for 4 cycles (control arm) in patients with stages III endometrial adenocarcinoma.'}, {'measure': 'adverse effect', 'timeFrame': 'through study completion,an average of 1 year', 'description': 'To compare the modalities with respect to acute and late adverse effects of therapy.'}, {'measure': 'patient-reported Quality of Life', 'timeFrame': '3 months after treatment and 1 year after treatment', 'description': 'To determine the impact on patient-reported Quality of Life (using the questionnaire of combining the items from FACT-G, FACT/GOG-NTX-4 subscale (4 items) and items C3 and C5 from the FACT-C)during and following treatment for up to 1 year with the two treatment regimens.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiochemotherapy', 'sanwich mode'], 'conditions': ['Endometrial Cancer']}, 'descriptionModule': {'briefSummary': 'Endometrial cancer is the most common gynecological malignancy affecting women\'s health. About 15% of the patients will have local late disease (stage III) with high risk of recurrence and tumor related mortality. There is a consensus that adjuvant radiochemotherapy is needed for stage Ⅲ endometrial cancer, but the best modality of radiochemotherapy is still uncertain. The retrospective data of our center showed that the sequential radiochemotherapy of "chemotherapy-radiotherapy-chemotherapy" in the "sanwich" mode could improve the survival outcome in patients with advanced endometrial cancer. A multicenter, prospective, randomized controlled study to compare the "sanwich" mode of radiochemotherapy and the "concurrent chemoradiotherapy followed by chemotherapy" mode will be carried out to determine the better modality of radiochemotherapy in stage III endometrial adenocarcinoma.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients of primary treatment\n2. All patients must have undertaken comprehensive staging operation（Surgery must have included a hysterectomy and bilateral salpingooophorectomy and surgical staging).\n3. Patients with endometrial adenocarcinoma confirmed by postoperative patholog.\n4. All patients with Surgical Stage III endometrial carcinoma according to FIGO 2009 staging criteria.\n5. Entry into the study is limited to no more than 8 weeks from the date of surgery.\n6. Patients with adequate organ function, reflected by the following parameters:\n\n 1. WBC ≥ Normal value of the institution;\n 2. Absolute neutrophil count (ANC) ≥ Normal value of the institution;\n 3. Platelet count ≥ 100,000/mcl;\n 4. SGOT, SGPT, and alkaline phosphatase ≤ 1.25 X upper limit of normal (ULN) ;\n 5. Bilirubin ≤ 1.5 X ULN;\n 6. Creatinine ≤ institutional ULN.\n7. Patients with a Karnofsky score≥60.\n8. The patients should voluntarily join the study, sign an approved informed consent with good compliance and cooperation with the follow-up.\n\nExclusion Criteria:\n\n1. Patients who have received prior adjuvant therapy (radiotherapy or chemotherapy or endocrine therapy).\n2. Patients with residual tumor after surgery.\n3. Patients with other invasive malignancies.\n4. Patients with contraindications of radiotherapy and chemotherapy (with a history of myocardial infarction within 3 month, unstable angina pectoris or history of uncontrolled arrhythmia s from the date of registration) and who cannot receive postoperative adjuvant radiotherapy and chemotherapy.\n5. Patients with an estimated survival of less than 6 months.\n6. Those who are unable or unwilling to comply with the research requirements'}, 'identificationModule': {'nctId': 'NCT04453904', 'briefTitle': 'Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Multicenter Randomized Controlled Study of Modalities of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer', 'orgStudyIdInfo': {'id': '2020PHB013-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sequential radiochemotherapy in a "sanwich" mode', 'description': 'Two courses of TC regimen chemotherapy (paclitaxel 135-175mg / m2; carboplatin AUC = 5; once every 21 days) will be given first, followed by external pelvic radiation (± vaginal brachytherapy), and then four courses of the same regime consolidation chemotherapy.', 'interventionNames': ['Other: sequential radiochemotherapy in a "sanwich" mode']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'concurrent chemoradiotherapy followed by chemotherapy', 'description': 'External pelvic radiation (± vaginal brachytherapy) will be given after operation. On the first day and the 29th day of radiotherapy, concurrent intravenous cisplatin (50mg/m2) will be given. After the concurrent radiochemotherapy, four courses of TC regimen (paclitaxel 135-175mg / m2; carboplatin AUC = 5; once every 21 days) chemotherapy will be given.', 'interventionNames': ['Other: sequential radiochemotherapy in a "sanwich" mode']}], 'interventions': [{'name': 'sequential radiochemotherapy in a "sanwich" mode', 'type': 'OTHER', 'description': 'Patients will randomized into two different modalities of radiochemotherapy.', 'armGroupLabels': ['concurrent chemoradiotherapy followed by chemotherapy', 'sequential radiochemotherapy in a "sanwich" mode']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianliu Wang, Doctor', 'role': 'CONTACT', 'email': 'wangjianliu@pkuph.edu.cn'}], 'facility': 'Jianliu Wang', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Guo Zhang, Ph.D', 'role': 'CONTACT', 'email': 'zhangguo-2005@163.com', 'phone': '+861088324381'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}