Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-02 @ 4:05 PM
Study NCT ID:
NCT01999933
Status:
UNKNOWN
Last Update Posted:
2013-12-03
First Post:
2013-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in 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': 'D011827', 'term': 'Radiation'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}, {'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': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-02', 'studyFirstSubmitDate': '2013-11-26', 'studyFirstSubmitQcDate': '2013-12-02', 'lastUpdatePostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '5-years'}], 'secondaryOutcomes': [{'measure': 'disease-free survival', 'timeFrame': '5 years'}, {'measure': 'acute adverse events', 'timeFrame': '3 months'}, {'measure': 'chronic adverse events', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cervical cancer', 'postoperative risk factor', 'treatment'], 'conditions': ['Cervical Cancer', 'Toxicity Due to Radiotherapy']}, 'descriptionModule': {'briefSummary': 'The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side effects will be evaluated according to Standard WHO response criteria, and NCI common toxicity criteria for adverse events(NCI-CTC-AE) V3.0.', 'detailedDescription': 'To the cervical cancer patient who accepted radical hysterectomy, whether the adjuvant therapy should be received or the method of adjuvant therapy are determined by the postoperative pathology. In the traditional opinion, the postoperative risk factors were divided into two groups: intermediate risk factors, including large tumor size, deep stromal invasion and lymphovascular space invasion, and high risk factors, including non-squamous cell carcinoma, marginal positive, parametric invasion and pelvic lymph node(LN) metastasis. Patients with intermediate risk factors should accepted adjuvant radiotherapy only and who with high risk factors should received adjuvant concurrent chemoradiotherapy. Cisplatin weekly(40mg/m2) was the standard regimen of concurrent chemotherapy. However, we retrospectively analyzed 801 cervical cancer patients with postoperative radiotherapy and found that distant metastasis was the main cause of current treatment failure(84.5%), which suggested the current regimen of chemotherapy was insufficient and might be strengthened in future.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 Years to 70 Years\n* Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy\n* Accepted radical hysterectomy 3-4 weeks before\n* Karnofsky score \\>70\n* Postoperative pathology with following risk factors: Non-squamous cell carcinoma, deep stromal invasion, lymphovascular space invasion, marginal positive, parametria invasion, large tumor size (tumor diameter\\>4cm) or pelvic LN metastasis. Patients with pelvic LN metastasis and combination of any two or more risk factors mentioned above were included.\n* Examination results showed no radiation or chemotherapy contraindication\n* Willing to accept treatment\n* Ability to comply with trial requirements\n\nExclusion Criteria:\n\n* Postoperative residual\n* Postoperative recurrence or metastasis\n* Without lymph node dissection\n* Postoperative pathology showed aortic lymph node metastasis\n* Examination results showed radiotherapy contraindications\n* No indications for radiotherapy'}, 'identificationModule': {'nctId': 'NCT01999933', 'briefTitle': 'Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Clinical Study on Docetaxel Plus Cisplatin(TP) Regimen Combined With Postoperative Radiotherapy for Stage Ia2- IIb Cervical Cancer', 'orgStudyIdInfo': {'id': 'XJFL-201309-CCPOSTOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CCRT with cisplatin(DDP) weekly', 'description': 'concurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation', 'interventionNames': ['Radiation: Radiation', 'Drug: cisplatin（DDP） weekly']}, {'type': 'EXPERIMENTAL', 'label': 'CCRT with TP', 'description': 'concurrent TP tri-weekly, docetaxel plus cisplatin tri-weekly (75mg/m2), begin with radiation', 'interventionNames': ['Radiation: Radiation', 'Drug: docetaxel plus cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'concurrent and adjuvant TP', 'description': '2 cycles of concurrent TP, docetaxel plus cisplatin tri-weekly (75mg/m2),begin with radiation; and 4 cycles of adjuvant TP, the same regimen, after radiation', 'interventionNames': ['Radiation: Radiation', 'Drug: docetaxel plus cisplatin']}], 'interventions': [{'name': 'Radiation', 'type': 'RADIATION', 'description': 'Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.', 'armGroupLabels': ['CCRT with TP', 'CCRT with cisplatin(DDP) weekly', 'concurrent and adjuvant TP']}, {'name': 'cisplatin（DDP） weekly', 'type': 'DRUG', 'description': 'concurrent chemotherapy with cisplatin（DDP） weekly(40mg/m2),begin with radiation', 'armGroupLabels': ['CCRT with cisplatin(DDP) weekly']}, {'name': 'docetaxel plus cisplatin', 'type': 'DRUG', 'description': 'concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation', 'armGroupLabels': ['CCRT with TP', 'concurrent and adjuvant TP']}, {'name': 'docetaxel plus cisplatin', 'type': 'DRUG', 'description': 'adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), 4 cycles after radiation', 'armGroupLabels': ['concurrent and adjuvant TP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mei Shi, MD', 'role': 'CONTACT', 'email': 'mshifmmu@yahoo.com', 'phone': '+86-029-84775425'}, {'name': 'Mei Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Li-Chun Wei, M.D.,Ph.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Mei Shi, MD.PhD', 'role': 'CONTACT', 'email': 'mshifmmu@yahoo.com', 'phone': '+86-029-84775425'}], 'overallOfficials': [{'name': 'Mei Shi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'department of radiation oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mei Shi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director and Professor of Department of Radiation Oncology, Xijing Hospital', 'investigatorFullName': 'Mei Shi', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}