Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-28 @ 12:34 AM
Study NCT ID:
NCT00359866
Status:
COMPLETED
Last Update Posted:
2016-06-15
First Post:
2006-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients
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': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-13', 'studyFirstSubmitDate': '2006-08-02', 'studyFirstSubmitQcDate': '2006-08-02', 'lastUpdatePostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the feasibility of using helical tomotherapy to deliver IMRT', 'timeFrame': 'After all patients are enrolled and complete treatment', 'description': 'Feasibility is defined as the ability to deliver 95% of the prescription dose to 90% of the original planning target volume in at least 90% of the patients, as verified by actual dose delivered calculations using on board CT scan.'}], 'secondaryOutcomes': [{'measure': 'Measure the acute toxicity', 'timeFrame': 'Up through 30 days after completion of treatment'}, {'measure': 'Measure the late toxicity', 'timeFrame': 'Starting 30 days from completion of treatment through 1 year post start of treatment'}, {'measure': 'Measure the local, regional, and distant recurrence rates', 'timeFrame': '5 years after completion of treatment'}, {'measure': 'Measure the 5-year disease free and 5-year overall survival rates', 'timeFrame': '5 years after completion of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uterine Cervical Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': "Indications for post-hysterectomy radiation therapy (RT) have been well established by clinical data. Adjuvant RT has demonstrated local control and survival benefit. In patients with nodal disease, adjuvant chemotherapy concurrent with radiation has further improved the clinical outcome. The acute hematological and gastrointestinal toxicity of concurrent chemo-radiotherapy can be quite high, sometimes preventing patients from completed their full treatment course, potentially compromising the therapeutic benefit of treatment. Intensity modulated radiation therapy (IMRT) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. Helical tomotherapy is a novel treatment device with sophisticated imaging and treatment delivery features that are optimally suited for IMRT. There are retrospective clinical data supporting the use of non-tomotherapy delivered IMRT to treat patients with gynecologic cancers. The proposed study will prospectively test whether helical tomotherapy is a feasible method for delivering IMRT in post-hysterectomy cervical cancer patients receiving adjuvant RT. Here, the question of feasibility is simply one of verifying that target volumes are reliably covered by 'sculpted' IMRT high-dose regions. Although this is not a treatment effectiveness study, we will also follow the clinical outcome of these patients, including toxicity, local control and survival, in anticipation that this information will be valuable if the treatment modality is judged feasible and will be used for further treatments of this patient population.", 'detailedDescription': 'Patients with cervical cancer receiving post-operative radiotherapy (RT) for high risk features found on pathologic review will be treated with pelvic intensity modulated radiation therapy (IMRT). Helical tomotherapy will be used to plan and deliver the radiation treatment. Treatment volume will include the upper third of the vagina and para-vaginal tissue and the common, external and internal iliac nodal regions. External beam radiation will be delivered in 180 cGy daily fractions to a total dose of 5040 cGy. Patients will receive once a day treatment five days a week, for approximately 6 weeks. Concurrent chemotherapy and/or intracavitary brachytherapy may be included in the treatment plan at the discretion of the treating physician, consistent with routine clinical practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18\n* Karnofsky Performance Status of \\>= 60\n* FIGO Stage I -IIB\n* Pathologic confirmation of cervical cancer\n* Status post hysterectomy\n* Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases\n\nExclusion Criteria:\n\n* Age \\< 18\n* Karnofsky Performance Status \\< 60\n* Radiographic or pathologic evidence of distant metastatic disease\n* Prior pelvic radiation therapy, other than trans-vaginal ring brachytherapy irradiation for acute hemostasis'}, 'identificationModule': {'nctId': 'NCT00359866', 'briefTitle': 'Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients', 'orgStudyIdInfo': {'id': '05-0977 / 201104019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pelvic IMRT with Tomotherapy', 'description': 'Helical tomotherapy will be used to plan and deliver the radiation treatment.\n\nTreatment volume will include the upper third of the vagina and para-vaginal tissue and the common, external and internal iliac nodal regions.\n\nExternal beam radiation will be delivered in 160-180 cGy daily fractions to a total dose of 4500-5120 cGY.\n\nReceive treatment once a day for five days a week for approximately 6 weeks.\n\nTreating physician will make determination if patient is to receive intracavitary brachytherapy.\n\nTreating physician will make determination if patient is to receive chemotherapy (allowed but not mandated).', 'interventionNames': ['Radiation: IMRT with tomotherapy']}], 'interventions': [{'name': 'IMRT with tomotherapy', 'type': 'RADIATION', 'armGroupLabels': ['Pelvic IMRT with Tomotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Perry W Grigsby, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}