Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT00278304
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2006-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation Therapy in Treating Patients With 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': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-04', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2006-01-16', 'studyFirstSubmitQcDate': '2006-01-16', 'lastUpdatePostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility'}, {'measure': 'Comparison of dose-volume estimations based on 3D imaging-based treatment planning, with the traditional point dose method based on orthogonal radiographs'}], 'secondaryOutcomes': [{'measure': 'Tolerance'}, {'measure': 'Toxicity'}, {'measure': 'Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity'}, {'measure': 'Disease status'}, {'measure': 'Time and patterns of relapse'}, {'measure': 'Survival distributions'}]}, 'conditionsModule': {'keywords': ['cervical adenocarcinoma', 'cervical adenosquamous cell carcinoma', 'cervical squamous cell carcinoma', 'stage IB cervical cancer', 'stage IIA cervical cancer', 'stage IIB cervical cancer', 'stage III cervical cancer', 'stage IVA cervical cancer', 'stage IVB cervical cancer'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving external-beam radiation together with internal radiation works in treating patients with cervical cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the feasibility of magnetic resonance-guided, endocavitary, high-dose rate brachytherapy implants in patients with stage IB-IVB cervical cancer.\n* Provide more reliable dose-volume estimations based on three-dimensional imaging-based treatment planning in patients treated with this regimen.\n\nSecondary\n\n* Determine the toxic effects and treatment tolerance in patients treated with this regimen.\n* Correlate three-dimensional dose-volume histograms of organs at risk with treatment toxicity in patients treated with this regimen.\n* Determine the disease status, time and patterns of relapse, and survival of patients treated with this regimen.\n\nOUTLINE: Patients undergo external beam radiotherapy 4-5 days a week for up to 7 weeks. Patients also undergo MRI-guided high-dose brachytherapy comprising one brachytherapy implant a week for 3-6 implants. Brachytherapy may be administered during or after external beam radiotherapy.\n\nAfter completion of study treatment, patients are followed periodically for 5 years.\n\nPROJECTED ACCRUAL: A total of 20 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 confirmed carcinoma of the cervix of 1 of the following cellular subtypes:\n\n * Squamous cell\n * Adenocarcinoma\n * Adenosquamous cell\n* Stages IB-IVA disease\n\n * Stage IVB disease allowed provided the impact on the quality of life is tremendous (e.g., "frozen pelvis" or massive pelvic disease and fistula formation, severe pain, or bleeding)\n* Measurable and/or evaluable disease on MRI\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* No physical or physiological capacity that would preclude study treatment\n* No cognitively impaired patients who cannot provide informed consent\n* Not pregnant or nursing\n* Negative pregnancy test\n* No contraindication to MRI, including any of the following:\n\n * Weight \\> 136 kg\n * Allergy to MR contrast agent\n * Pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices\n* No significant unrelated systemic illness\n* No serious infections\n* No significant cardiac, pulmonary, hepatic, or other organ dysfunction that would preclude study treatment\n* Must be medically fit to receive anesthesia\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior definitive brachytherapy procedures\n\n * Ring implants or intravaginal cones for the relief of excessive bleeding allowed\n* No prior definitive surgical oncologic procedures (e.g., radical hysterectomy)\n* Concurrent chemotherapy, immunotherapy, or hormonal therapy allowed'}, 'identificationModule': {'nctId': 'NCT00278304', 'briefTitle': 'Radiation Therapy in Treating Patients With Cervical Cancer', 'nctIdAliases': ['NCT00214396'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Pilot Study of MR-Guided High Dose Rate Brachytherapy With MR Image Acquisition for Patients With Cervical Cancer', 'orgStudyIdInfo': {'id': 'CDR0000454997'}, 'secondaryIdInfos': [{'id': 'NCI-05-C-0233'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'brachytherapy', 'type': 'RADIATION'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892-1182', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Shervin Karimpour, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NCI - Radiation Oncology Branch; ROB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}