Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-02 @ 5:55 AM
Study NCT ID:
NCT01304667
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2011-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemo- and Radiotherapy in Epithelial Vulvar Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014846', 'term': 'Vulvar Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014845', 'term': 'Vulvar 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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Subproject of Translational Research:\n\nParaffin embedded tissue samples were collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1618}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2011-02-24', 'studyFirstSubmitQcDate': '2011-02-24', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of several specific characteristics', 'timeFrame': 'Data from vulvar cancer pts between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radi', 'description': '* Determination of the fraction of node positive patients to estimate the number of participating centers and sample size for a subsequent prospective trial.\n* Determination of the prognostic impact of the number of positive lymph nodes and the stage of disease to define indication criteria for adjuvant radio/chemotherapy for a subsequent prospective trial.\n* Identification of indication criteria for adjuvant/therapeutic/palliative radio/chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vulvar cancer', 'Radiotherapy', 'Chemotherapy'], 'conditions': ['Radio/Chemotherapy in Node Positive Advanced Vulvar Cancer']}, 'referencesModule': {'references': [{'pmid': '25618900', 'type': 'RESULT', 'citation': 'Mahner S, Jueckstock J, Hilpert F, Neuser P, Harter P, de Gregorio N, Hasenburg A, Sehouli J, Habermann A, Hillemanns P, Fuerst S, Strauss HG, Baumann K, Thiel F, Mustea A, Meier W, du Bois A, Griebel LF, Woelber L; AGO-CaRE 1 investigators. Adjuvant therapy in lymph node-positive vulvar cancer: the AGO-CaRE-1 study. J Natl Cancer Inst. 2015 Jan 24;107(3):dju426. doi: 10.1093/jnci/dju426. Print 2015 Mar.'}]}, 'descriptionModule': {'briefSummary': 'This retrospective, multicenter study is designed to collect tumor characteristics as well as treatment data from patients diagnosed with primary or recurrent squamous cell cancer of the vulva with emphasis on indication and application of radio- and chemotherapy. Application of chemotherapy in primary treatment of vulvar cancer is rare; the study collective is therefore extended to relapsed disease.', 'detailedDescription': 'All patients with primary squamous cell cancer of the vulva \\> stage Ia who were diagnosed and received treatment between 1998 and 2008 at the participating centres will be included in the study. Furthermore patients with recurrent disease diagnosed and treated at the participating centres during the same time period can be included given that they not only underwent surgical excision for treatment.\n\nFor centers with restricted resources for data entry an alternative study collective was defined:\n\nAll Patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or chemotherapy for treatment at the participating centres between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radio/chemotherapy for other reasons.\n\nThe participating centers themselves have to decide which study collective they are documenting, dependent on their available resources.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective, multicenter study is designed to collect tumor characteristics as well as treatment data from patients diagnosed with primary or recurrent squamous cell cancer of the vulva with emphasis on indication and application of radio- and chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with primary squamous cell vulvar cancer except stage Ia disease regardless of the received treatment\n2. Patients with recurrent squamous cell vulvar cancer, if the relapse was not only treated with a surgical excision.\n3. Or alternatively, dependent on the decision of the participating center:\n\n -Patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or chemotherapy for treatment regardless of nodal involvement.\n4. Patients who were diagnosed with and treated for primary or relapsed vulvar cancer between 1998 and 2008\n5. Women aged ≥ 18 years\n\nExclusion Criteria:\n\n1. Patients with benign or precursor lesions (VIN - vulvar intraepithelial neoplasia) of the vulva\n2. Patients with non-squamous neoplasia of the vulva (e.g. melanoma)\n3. Patients with verrucous vulvar cancer\n4. Patients with relapsed squamous cell vulvar cancer only receiving surgical excision for treatment.\n5. Patients with secondary cancers if those interfered with the treatment of vulvar disease'}, 'identificationModule': {'nctId': 'NCT01304667', 'acronym': 'CARE', 'briefTitle': 'Chemo- and Radiotherapy in Epithelial Vulvar Cancer', 'organization': {'class': 'OTHER', 'fullName': 'AGO Study Group'}, 'officialTitle': 'Chemo- and Radiotherapy in Epithelial Vulvar Cancer', 'orgStudyIdInfo': {'id': 'AGO-VOP.1 / CARE'}}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Sven Mahner, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Gynecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AGO Study Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'medac GmbH', 'class': 'INDUSTRY'}, {'name': 'Philipps University Marburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}