Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT01461759
Status:
UNKNOWN
Last Update Posted:
2017-05-31
First Post:
2011-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Chemotherapy to Treat Advanced or Recurrent 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 59}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-27', 'studyFirstSubmitDate': '2011-10-25', 'studyFirstSubmitQcDate': '2011-10-27', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '3 months after completion of study treatment'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '2 years after completion of study treatment'}, {'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Before each chemotherapy, an expected average of 3 weeks'}, {'measure': 'Quality of life', 'timeFrame': '3 months after completion of study treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced or Recurrent Endometrial Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to treat advanced or recurrent endometrial cancer, paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by most physicians. Docetaxel may have similar efficacy and more favorable treatment related toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with advanced or recurrent endometrial cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed chemotherapy naïve endometrial cancer\n* One of following histology Endometrioid, UPSC, CCCa, squamous, adenosquamous, mixed\n* FIGO stage IVb or recurrent endometrial cancer (incurable by surgery and/or RT)\n* At least one measurable lesion by RECIST on CT\n* ECOG PS: 0-2\n* Age: 20-75\n* Adequate organ function BM: ANC≥1,000/mm3, Plt≥100X103/mm3 Kidney: Creatinine\\<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT\\< 3×UNL, T- bil\\<1.5 mg/ mm3\n* Informed Consent\n* Contraception during study period\n\nExclusion Criteria:\n\n* Previous chemotherapy\n* RT, hormone therapy, or immunotherapy within 1 month\n* Other malignant disease\n* Uncontrolled medical disease\n* Infection requiring antibiotics\n* Symptomatic CHF, RF, Angina, Arrhythmia, etc.\n* Neurosis or psychosis\n* Pregnancy, breast-feeding\n* Etc.'}, 'identificationModule': {'nctId': 'NCT01461759', 'briefTitle': 'Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer', 'orgStudyIdInfo': {'id': 'ANSGOG-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemotherapy', 'description': 'Docetaxel 70mg/m2BSA + Cisplatin 60mg/m2BSA, q 3 weeks, 8cycles', 'interventionNames': ['Drug: Doctaxel', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Doctaxel', 'type': 'DRUG', 'description': 'Docetaxel 70mg/m2BSA, q 3 weeks, 8 cycles', 'armGroupLabels': ['Chemotherapy']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin 60mg/m2BAS, q 3 weeks, 8 cycles', 'armGroupLabels': ['Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joo-Hyun Nam, M.D., Ph.D', 'role': 'CONTACT', 'email': 'jhnam@amc.seoul.kr', 'phone': '+82-2-3010-3633'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Joo-Hyun Nam, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'jhnam@amc.seoul.kr', 'phone': '+82-2-3010-3633'}, {'name': 'Jeong-Yeol Park, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'obgyjypark@amc.seoul.kr', 'phone': '+82-2-3010-3646'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joo-Hyun Nam', 'investigatorAffiliation': 'Asan Medical Center'}}}}