Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:45 PM
Study NCT ID:
NCT00842660
Status:
UNKNOWN
Last Update Posted:
2010-01-05
First Post:
2009-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in Defined Poor-Prognostic 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': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 172}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-01-03', 'studyFirstSubmitDate': '2009-02-08', 'studyFirstSubmitQcDate': '2009-02-11', 'lastUpdatePostDateStruct': {'date': '2010-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient survival, including overall survival and progression-free survival.', 'timeFrame': '2012,'}], 'secondaryOutcomes': [{'measure': '1) Acute toxicity during treatment 2) Tumor response rates 3) Sites of recurrence 4) Long-term complications and quality of life', 'timeFrame': '2013'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cervical cancer', 'concurrent chemoradiotherapy', 'gemcitabine'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'references': [{'pmid': '25827291', 'type': 'DERIVED', 'citation': 'Wang CC, Chou HH, Yang LY, Lin H, Liou WS, Tseng CW, Liu FY, Liou JD, Huang KG, Huang HJ, Huang EY, Chen CH, Chang TC, Chang CJ, Hong JH, Lai CH. A randomized trial comparing concurrent chemoradiotherapy with single-agent cisplatin versus cisplatin plus gemcitabine in patients with advanced cervical cancer: An Asian Gynecologic Oncology Group study. Gynecol Oncol. 2015 Jun;137(3):462-7. doi: 10.1016/j.ygyno.2015.03.046. Epub 2015 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, in patients with advanced cervical cancer, half of them treated with contemporary radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation.\n\nThe major aim of this project is to conduct a prospective, randomized phase III clinical trial to examine if cervical cancer patients treated by radiotherapy with cisplatin and gemcitabine have better survival rates than those treated by radiotherapy with cisplatin alone.\n\nGemcitabine has been demonstrated to be a good radiosensitizer. In keeping with this, few clinical trials in early phases showed promising results when using concurrent radiotherapy with cisplatin and gemcitabine. According to these positive results, the investigators expect this trial has the potential to improve the survival in patients with advanced cervical cancer, reduce the medical costs due to tumor relapse, and then benefit the whole society.', 'detailedDescription': 'I). Study end points Primary end point: Patient survival, including overall survival and progression-free survival.\n\nSecondary end points:\n\n1. Acute toxicity during treatment\n2. Tumor response rates\n3. Sites of recurrence\n4. Long-term complications and quality of life II). Design of study\n\nAn open-label, prospective randomized trial with two treatment arms:\n\n* Arm I: Patients receive CCRT with weekly cisplatin only.\n* Arm II: Patients receive CCRT with cisplatin plus gemcitabine. III). Study population 1) Number of subjects: A total of 172 patients (86 per treatment arm) will be accrued for this study within 4 years.\n\nConduct of study'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed primary squamous cell carcinoma of the uterine cervix.\n* Previously untreated disease.\n* Clinical FIGO stage III-IVa or pelvic/para-aortic lymph node positive by PET examination.\n* No known metastases to supraclavicular nodes or other organs outside the radiotherapy field.\n* Ages eligible: 35 years - 70 years.\n* Patients must have adequate bone marrow, pulmonary, liver and renal function documented before radiotherapy. WBC \\> 3000/mm3, platelet \\> 100,000/mm3, serum transaminases (GOT, GPT) \\< 60 IU/ml, total bilirubin \\< 1.5mg%, creatinine \\< 1.4mg% (creatinine clearance \\> 60 ml/min).\n* Performance status 0 or 1 (see Appendix I).\n* The interval between RT and randomization is not greater than 3 weeks.\n* Patients must have signed informed consent to participate this study.\n\nExclusion Criteria:\n\n* Age \\> 70 or \\< 35\n* Medical or psychological condition that would preclude treatment.\n* Previous chemotherapy or pelvic RT.\n* Small cell carcinoma, adenocarcinoma or adenosquamous carcinoma.\n* Patient unreliable for treatment completion and follow-up.'}, 'identificationModule': {'nctId': 'NCT00842660', 'briefTitle': 'Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in Defined Poor-Prognostic Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Phase III Trial for Primary Radiotherapy With Single-Agent Cisplatin or Combination Chemotherapy in PET/CT Defined Poor-Prognostic Cervical Cancer Patients', 'orgStudyIdInfo': {'id': '97-1165A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemzar,survival', 'interventionNames': ['Drug: Gemzar (gemcitabine)']}], 'interventions': [{'name': 'Gemzar (gemcitabine)', 'type': 'DRUG', 'otherNames': ['GEMCITABINE'], 'description': "Gemzar(gemcitabine) Hcl has 2'deoxy-2,2'-difluorouridine monohydrochloride", 'armGroupLabels': ['Gemzar,survival']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M.D', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Chong Jong Wang,', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Keelung', 'country': 'Taiwan', 'facility': 'Chien-Sheng Tsai', 'geoPoint': {'lat': 25.13089, 'lon': 121.74094}}], 'overallOfficials': [{'name': 'Chun Chieh Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Department of Obstetrics & Gynecology', 'oldOrganization': 'Chang Gung Memorial Hospital'}}}}