Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT00217633
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
2005-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pelvic Exenteration in Treating Patients With Recurrent 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2005-09-20', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From entry to protocol to death; or for living patients, the date of last contact, up to 93 years'}, {'measure': 'Progression-free survival', 'timeFrame': 'From study entry to date of reappearance or increasing parameters of disease or death, or to date of last contact for patients without disease progression, up to 93 years'}], 'secondaryOutcomes': [{'measure': 'Impact of surgery therapy (exenteration and reconstructive surgery type) on quality of life assessed by Functional Assessment of Cancer Therapy-Cervix (FACT-CX)', 'timeFrame': 'At baseline, 6, 12, and 24 months post exenteration'}]}, 'conditionsModule': {'conditions': ['Cervical Adenocarcinoma', 'Cervical Adenosquamous Carcinoma', 'Cervical Small Cell Carcinoma', 'Cervical Squamous Cell Carcinoma', 'Recurrent Cervical Carcinoma']}, 'descriptionModule': {'briefSummary': 'This phase II trial is studying how well pelvic exenteration works in treating patients with recurrent cervical cancer. Pelvic exenteration may be effective in treating recurrent cervical cancer.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. Correlate progression-free survival and overall survival with tumor size, time interval between primary cancer management and pelvic exenteration, and presence or absence of pelvic sidewall fixation by clinical examination in patients with recurrent cervical cancer treated with pelvic exenteration.\n\nSECONDARY OBJECTIVES:\n\nI. Determine quality of life of patients treated with this procedure. II. Correlate quality of life with reconstructive technique (e.g., no ostomy or ≥ 1 ostomy) in patients treated with this procedure.\n\nOUTLINE:\n\nPatients undergo pelvic exenteration within 14 days after study entry. Quality of life is assessed at baseline and at 6, 12, and 24 months after surgery. After completion of study treatment, patients are followed within 30 days, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cervical cancer\n\n * Any histology\n * Documented or suspected central pelvic disease with or without pelvic sidewall fixation from tumor and/or radiation fibrosis\n* Meets 1 of the following stage criteria:\n\n * Recurrent disease, defined as reappearance of disease after a complete clinical response lasting ≥ 1 month\n * Persistent disease, defined as presence of disease by biopsy ≥ 3 months after completion of primary therapy\n* Must have received prior primary treatment, including any of the following:\n\n * Surgery with or without post operative radiotherapy with or without chemotherapy\n * Primary radiotherapy with or without chemotherapy\n * Neoadjuvant chemotherapy followed by surgery\n * Neoadjuvant chemotherapy followed by surgery with or without radiotherapy or chemotherapy\n* Plans to undergo pelvic exenteration to remove the pelvic disease within 14 days after study entry\n\n * Deemed to be a good surgical candidate\n\n * No evidence of distant disease or disease that is felt to be unresectable by physical examination\n * Patients with suspicious pelvic or para-aortic nodal disease as the only site(s) of extrapelvic disease are eligible at the discretion of the surgeon\n * Patients whose surgery is planned solely for managing complications (e.g., rectovaginal fistula, vesicovaginal fistula) of disease or prior therapy are not eligible\n * Patients whose surgery is planned as a prophylactic measure due to a slow or suboptimal clinical or radiographical tumor response during the course of primary therapy are not eligible\n* No distant site of metastases by CT scan or MRI of the abdomen/pelvis OR positron-emission tomography\n* No noncervical primary tumor\n* No prior anterior or posterior pelvic exenteration'}, 'identificationModule': {'nctId': 'NCT00217633', 'briefTitle': 'Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer', 'orgStudyIdInfo': {'id': 'GOG-0222'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00593', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000442396'}, {'id': 'GOG-0222', 'type': 'OTHER', 'domain': 'Gynecologic Oncology Group'}, {'id': 'GOG-0222', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA027469', 'link': 'https://reporter.nih.gov/quickSearch/U10CA027469', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (pelvic exenteration)', 'description': 'Patients undergo pelvic exenteration within 14 days after study entry.', 'interventionNames': ['Procedure: Conventional Surgery']}], 'interventions': [{'name': 'Conventional Surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Treatment (pelvic exenteration)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80010', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Gynecologic Oncology Group', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06050', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Hospital of Central Connecticut', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '19958', 'city': 'Lewes', 'state': 'Delaware', 'country': 'United States', 'facility': 'Beebe Medical Center', 'geoPoint': {'lat': 38.77456, 'lon': -75.13935}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health System-Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Regents University Medical Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '31404', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Memorial University Medical Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University/Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21921', 'city': 'Elkton MD', 'state': 'Maryland', 'country': 'United States', 'facility': 'Union Hospital of Cecil County'}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center-Fairview', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08690', 'city': 'Hamilton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Cancer Institute of New Jersey Hamilton', 'geoPoint': {'lat': 40.20706, 'lon': -74.08125}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44111', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Cancer Center/Fairview Hospital', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hillcrest Hospital Cancer Center', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lake University Ireland Cancer Center', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Care Associates-Midtown', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '74146', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Tulsa Cancer Institute', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Gynecologic Oncology Group', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98001', 'city': 'Auburn', 'state': 'Washington', 'country': 'United States', 'facility': 'Auburn Regional Medical Center', 'geoPoint': {'lat': 47.30732, 'lon': -122.22845}}, {'zip': '98531', 'city': 'Centralia', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Regional Cancer System-Centralia', 'geoPoint': {'lat': 46.71621, 'lon': -122.9543}}, {'zip': '98003', 'city': 'Federal Way', 'state': 'Washington', 'country': 'United States', 'facility': 'Saint Francis Hospital', 'geoPoint': {'lat': 47.32232, 'lon': -122.31262}}, {'zip': '98499', 'city': 'Lakewood', 'state': 'Washington', 'country': 'United States', 'facility': 'Saint Clare Hospital', 'geoPoint': {'lat': 47.17176, 'lon': -122.51846}}, {'zip': '98506-5166', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence - Saint Peter Hospital', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'zip': '98507', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Capital Medical Center', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'zip': '98372', 'city': 'Puyallup', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Good Samaritan Hospital', 'geoPoint': {'lat': 47.18538, 'lon': -122.2929}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Allenmore Hospital', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Tacoma General Hospital', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest CCOP', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Saint Joseph Medical Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '98415', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Multicare Health System', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '28033', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'M D Anderson International Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'D. McMeekin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynecologic Oncology Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}