Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT00373620
Status:
UNKNOWN
Last Update Posted:
2006-09-08
First Post:
2006-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients
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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'lastUpdateSubmitDate': '2006-09-06', 'studyFirstSubmitDate': '2006-09-06', 'studyFirstSubmitQcDate': '2006-09-06', 'lastUpdatePostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Two year progression free survival'}], 'secondaryOutcomes': [{'measure': 'toxicity profile'}]}, 'conditionsModule': {'keywords': ['endometrial cancer', 'high risk', 'weekly paclitaxel', 'Cuncurrent chemoradiation'], 'conditions': ['Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '25015202', 'type': 'DERIVED', 'citation': 'Cho H, Nam BH, Kim SM, Cho CH, Kim BG, Ryu HS, Kang SB, Kim JH. A phase 2 trial of radiation therapy with concurrent paclitaxel chemotherapy after surgery in patients with high-risk endometrial cancer: a Korean Gynecologic Oncologic Group study. Int J Radiat Oncol Biol Phys. 2014 Sep 1;90(1):140-6. doi: 10.1016/j.ijrobp.2014.05.024. Epub 2014 Jul 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether post-operative concurrent chemoradiation with paclitaxel is effective and safe in the treatment of high risk postoperative endometrial cancer patients.', 'detailedDescription': "Postoperative radiotherapy (RT) is the most used adjuvant treatment in high risk endometrial cancer (HREC), and it appears to reduce the incidence of pelvic relapses but doesn't seem to improve survival. Paclitaxel (P) has shown in vitro and clinical activity against endometrial cancer, and it is also a potent radiosensitizer by blocking dividing cells in G2/M phase. This study is to evaluate the efficacy and safety of a treatment with concomitant weekly chemotherapy with paclitaxel and RT in high risk advanced endometrial cancer."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undertaken total hysterectomy, bilateral salpingoophorectomy, washing cytology, pelvic and paraaortic lymph node dissection\n* Patients must have the diagnosis of endometrioid type adenocarcinoma with stage III, IV.\n* Patients must have a GOG performance of 0, 1, or 2.\n* Patients must have expected life span over 6 months.\n\nExclusion Criteria:\n\n* Patients with peripheral neurotoxicity over grade 2 in CTC criteria.\n* Patients with history of chemotherapy or radiation treatment.\n* patients with history of arrhythmia,congestive heart failure.\n* Patients with intractable infection.'}, 'identificationModule': {'nctId': 'NCT00373620', 'briefTitle': 'A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Korean Gynecologic Oncology Group'}, 'officialTitle': 'A Phase II Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy in High-Risk Endometrial Cancer Patients After Operation.', 'orgStudyIdInfo': {'id': 'KGOG2001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'paclitaxel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-720', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae-Hoon Kim, Professor', 'role': 'CONTACT', 'email': 'jaehoonkim@yumc.yonsei.ac.kr', 'phone': '+82-2-2019-3436'}, {'name': 'Jae Weon Kim, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Noh Hyun Park, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Soon Beom Kang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Young-Dong Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jae-Hoon Kim, Professor', 'role': 'CONTACT', 'email': 'jaehoonkim@yumc.yonsei.ac.kr', 'phone': '+82-2-2019-3436'}, {'name': 'Hyun Hoon Chung, Fellow', 'role': 'CONTACT', 'email': 'chhkmj1@snu.ac.kr', 'phone': '+82-2-2072-2821'}], 'overallOfficials': [{'name': 'Jae-Hoon Kim, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Yong-Dong Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korean Gynecologic Oncology Group', 'class': 'OTHER'}}}}