Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT02629718
Status:
UNKNOWN
Last Update Posted:
2018-03-16
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy + Surgery Versus Surgery in FIGO IB2 and IIA2 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': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'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': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': 700}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-14', 'studyFirstSubmitDate': '2015-12-10', 'studyFirstSubmitQcDate': '2015-12-11', 'lastUpdatePostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '5 years'}, {'measure': 'quality of life', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neoadjuvant chemotherapy', 'radical surgery', 'cervical carcinoma'], 'conditions': ['PFS', 'OS', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'To clarify the potential benefits of NACT before radical surgery(RS), we perform a phase III, randomised controlled trial to compare NACT plus RS with RS alone in patients with stages IB2 and IIA2 cervical cancer.', 'detailedDescription': 'Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IB2 and IIA2 cervical cancer are eligible for our study. They will receive paclitaxel + cisplatin(TP)/carboplatin(TC) regimen neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or directly radical surgery (arm B). Postoperative pelvic radiotherapy will be started within 6 weeks after surgery if the patients have pelvic lymph node metastasis, parametrial involvement, deep stromal invasion or positive margin. Extended-field external beam therapy, delivering a dose of 4500cGy by a four-field technique, will be administered to patients with positive para-aortic nodes. High-dose rate brachytherapy will be delivered to the vaginal stump if patients have positive surgical margins. The primary end point is 2-years progression-free survival, The secondary end points is overall survival , rate of response to TP or TC regimen chemotherapy and the quality of life.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with newly histologically confirmed cervical carcinoma;\n* Histopathology squamaous carcinoma, adenocarcinoma or adeno-squamous carcinoma;\n* Original clinical stage must be IB2 or IIA2 （FIGO);\n* Age between 18-65;\n* Patients must give signed informed consent;\n* P.S status: 0-1;\n* Estimated survival time \\> 3 months;\n\nExclusion Criteria:\n\n* The presence of uncontrolled life-threatening illness;\n* Receiving other ways of anti-cancer therapy;\n* Investigator consider the patients can't finish the whole study;\n* With normal liver function test (ALT、AST\\>2.5×ULN);\n* With normal renal function test (Creatinine\\>1.5×ULN);\n* WBC\\<4,000/mm3 or PLT\\<100,000/mm;\n* Accompany with other malignancy."}, 'identificationModule': {'nctId': 'NCT02629718', 'acronym': 'SYSGO-003', 'briefTitle': 'Neoadjuvant Chemotherapy + Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Trial of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery in FIGO IB2 and IIA2 Cervical Cancer(CSEM005)', 'orgStudyIdInfo': {'id': '2015-FXY-069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A(NACT)', 'description': 'Neoadjuvant Chemotherapy followed by Radical Surgery', 'interventionNames': ['Drug: NACT (Paclitaxel + Cisplatin or carboplatin)', 'Procedure: radical surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B(RS)', 'description': 'Radical Surgery alone', 'interventionNames': ['Procedure: radical surgery']}], 'interventions': [{'name': 'NACT (Paclitaxel + Cisplatin or carboplatin)', 'type': 'DRUG', 'description': 'Paclitaxel 150mg/m2 over 3 hours + Cisplatin 70mg/m2 or carboplatin AUC = 6, repeat per 21 days, 3 cycles.', 'armGroupLabels': ['A(NACT)']}, {'name': 'radical surgery', 'type': 'PROCEDURE', 'description': 'Radical hysterectomy (Piver Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling', 'armGroupLabels': ['A(NACT)', 'B(RS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Wan, Ph.D', 'role': 'CONTACT'}], 'facility': 'Sun Yat-sen University Cancer Center, Department of Gynecologic Oncology', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Jihong Liu, Ph. D', 'role': 'CONTACT', 'email': 'Liujih@mail.sysu.edu.cn', 'phone': '86-20-87343102'}, {'name': 'Ting Wan, Ph. D', 'role': 'CONTACT', 'email': 'wanting@sysucc.org.cn', 'phone': '86-20-87343014'}], 'overallOfficials': [{'name': 'Jihong Liu, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Jihong Liu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}