Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT01474356
Status:
COMPLETED
Last Update Posted:
2011-11-18
First Post:
2011-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperthermia Combined Brachytherapy in CCU
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': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-15', 'studyFirstSubmitDate': '2011-10-20', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2011-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LC', 'timeFrame': 'Follow up was scheduled every 3 months. Preliminary results after 3 years.', 'description': 'When local relapse was suspected, biopsy was obtained.'}], 'secondaryOutcomes': [{'measure': 'Late side effects', 'timeFrame': 'Follow up was scheduled every 3 months. Preliminary results after 3 years.', 'description': 'EORTC\\\\ERTOG scale for rectum and bladder and SOMA scale for vagina'}, {'measure': 'Early complications of BT procedure', 'timeFrame': '24 hours after BT procedure', 'description': 'Reporting the episodes of perforation and bleeding.'}, {'measure': 'DFS', 'timeFrame': 'Follow up was scheduled every 3 months. Preliminary results after 3 years.', 'description': 'CT, RTG, MRJ, SCC are performed to detect metastases.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['brachytherapy', 'interstitial hyperthermia', 'cervical cancer', 'side effects', 'Locally advanced cervical cancer patients'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this randomised trial was to investigate whether hyperthermia (HT) combined with interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free survival (DFS), or acute and late side effects in patients with advanced cervical cancer. Vaginal symptoms were assessed by SOMA score, bladder and rectum symptoms by EORTC/RTOG score. Following the completion of radiochemotherapy, consecutive patients with cervical cancer (FIGO stage II - III) were randomly assigned to two treatment groups, either ISBT alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were included in the statistical analysis. Once a week, HT, at a temperature above 42.5°C, was administered for 45 minutes before and during the HDR BT. Follow-up examinations were scheduled at 6 weeks after the completion of BT, every 3 months during the first 2 years, and every 6 months throughout the next 3 years. If relapse was suspected, biopsies were obtained from these patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with locally advanced cervical cancer FIGO stage II - III\n* signed informed consent for participation in the study\n\nExclusion Criteria:\n\n* patients with FIGO stage I and IV\n* patients with poor performance status with contraindications for radical treatments'}, 'identificationModule': {'nctId': 'NCT01474356', 'briefTitle': 'Hyperthermia Combined Brachytherapy in CCU', 'organization': {'class': 'OTHER', 'fullName': 'Maria Sklodowska-Curie National Research Institute of Oncology'}, 'officialTitle': 'HDR Brachytherapy Combined With Interstitial Hyperthermia 500 kHz in Locally Advanced Cervical Cancer Patients. A Prospective Clinical Trial', 'orgStudyIdInfo': {'id': 'HTCCU01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'BT (brachytherapy)', 'description': 'Cervical cancer patients after the treatment with external beam radiotherapy combined with chemotherapy. In this group of patients, interstitial brachytherapy only was performed.', 'interventionNames': ['Other: hyperthermia']}, {'type': 'EXPERIMENTAL', 'label': 'BTHT (brachytherapy and hyperthermia)', 'description': 'Cervical cancer patients after the treatment with external beam radiotherapy combined with chemotherapy. In this group of patients, interstitial brachytherapy with interstitial hyperthermia was performed.', 'interventionNames': ['Other: hyperthermia']}], 'interventions': [{'name': 'hyperthermia', 'type': 'OTHER', 'description': '45 minutes of interstitial heating 42.5-49°C during the interstitial brachytherapy', 'armGroupLabels': ['BT (brachytherapy)', 'BTHT (brachytherapy and hyperthermia)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Maria Skłodowska-Curie Memorial Cancer Center and Institute', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Agnieszka Żółciak-Siwińska, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'M. Sklodowska-Curie Memorial Cancer Centre and Institute, Roentgena 5, 02-781 Warsaw, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Sklodowska-Curie National Research Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}