Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT00008112
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2001-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cisplatin Combined With Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV 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': 'D002945', 'term': 'Cisplatin'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-10', 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2001-01-06', 'studyFirstSubmitQcDate': '2003-06-04', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-05', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage III cervical cancer', 'stage IIB cervical cancer', 'stage IVA cervical cancer', 'cervical squamous cell carcinoma', 'cervical adenocarcinoma', 'cervical adenosquamous cell carcinoma'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with radiation therapy and chemotherapy may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of cisplatin combined with radiation therapy and hyperthermia in treating patients who have stage II, stage III, or stage IV cervical cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility of adding cisplatin and locoregional hyperthermia to external beam and intracavity radiotherapy in patients with stage IIB-IVA cervical cancer.\n* Determine the acute toxicity of this regimen in these patients.\n* Determine the complete response rate of patients treated with this regimen.\n\nOUTLINE: This is a multicenter study.\n\nPatients undergo external beam radiotherapy (EBRT) once daily 5 days a week for 5 weeks. On 1 day of each week, patients also receive cisplatin IV over 3 hours and hyperthermia over 90 minutes beginning 1-6 hours after completion of EBRT. During week 6, patients receive hyperthermia and cisplatin on the day before the 1 day of intracavity radiotherapy. Treatment continues in the absence of unacceptable toxicity.\n\nPatients are followed at 6-8 weeks, every 3 months for 3 years, and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 6-34 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed stage IIB-IVA carcinoma of the cervix\n\n * Adenocarcinoma\n * Squamous cell carcinoma\n * Mixed cell histology\n * No small cell anaplastic histology\n* No para-aortic lymph node involvement\n\n * No indication for para-aortic radiotherapy\n* No distant metastases\n* No CNS disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* WHO 0-2\n\nLife expectancy:\n\n* More than 3 months\n\nHematopoietic:\n\n* WBC at least 3,000/mm\\^3\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 7.0 mmol/L (approximately 11 g/dL)\n* Epoetin alfa and/or transfusion allowed\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Glomerular filtration rate at least 60 mL/min\n\nCardiovascular:\n\n* No myocardial infarction within the past 6 months\n* No unstable angina\n* No congestive heart failure with expected inability to tolerate fluid load\n* No cerebrovascular accident within the past 6 months\n\nOther:\n\n* No pacemaker and/or metal implants\n* No active uncontrolled infection\n* No compromised immune status\n* No psychosis\n* No other prior malignancy except nonmelanoma skin cancer\n* No mental or other physical inability that would preclude study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* No prior radiotherapy\n\nSurgery:\n\n* No prior surgery'}, 'identificationModule': {'nctId': 'NCT00008112', 'briefTitle': 'Cisplatin Combined With Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Feasibility Study of the Combination of Radiotherapy, Chemotherapy and Hyperthermia for the Treatment of Stage IIB-III-IVA Cervical Cancer', 'orgStudyIdInfo': {'id': 'DUT-KWF-CKVO-2000-02'}, 'secondaryIdInfos': [{'id': 'CDR0000068376', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EU-20036'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'hyperthermia treatment', 'type': 'PROCEDURE'}, {'name': 'brachytherapy', 'type': 'RADIATION'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3000 CA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'University Hospital - Rotterdam Dijkzigt', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3075 EA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Rotterdam Cancer Institute', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Anneke M. Westermann, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}}}}