Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT01180504
Status:
UNKNOWN
Last Update Posted:
2010-08-12
First Post:
2010-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-11', 'studyFirstSubmitDate': '2010-08-11', 'studyFirstSubmitQcDate': '2010-08-11', 'lastUpdatePostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compatibility of the treatment', 'timeFrame': 'Beginning of radiotherapy till 6 weeks after its completion', 'description': 'Therapy compatibility defined as non-occurrence of life-threatening grade 4 (CTCAE v3.0) acute toxicity'}], 'secondaryOutcomes': [{'measure': 'Rate of incomplete radiotherapy', 'timeFrame': '4 weeks', 'description': 'Rate of incomplete radiotherapy due to treatment toxicity'}, {'measure': 'Rate of delayed radiotherapy', 'timeFrame': '4 weeks', 'description': 'Rate of delayed radiotherapy due to treatment toxicity'}, {'measure': 'Acute toxicity', 'timeFrame': 'From the beginning of radiotherapy till 6 weeks after its completion', 'description': 'Graded according CTCAE Version 3.0'}, {'measure': 'Late Toxicity', 'timeFrame': '6 weeks -3 years after the completion of radiotherapy', 'description': 'Graded according CTCAE Version 3.0'}, {'measure': 'Overall survival', 'timeFrame': '3 years'}, {'measure': 'Disease-free survival', 'timeFrame': '3 years after the completion of radiotherapy'}, {'measure': 'Quality of life', 'timeFrame': '3 years', 'description': 'assessed using EORTC QLQ-C30 Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ovarian cancer', 'whole-abdominal radiotherapy', 'consolidation treatment', 'helical tomotherapy'], 'conditions': ['Ovarian Cancer', 'Tubal Carcinoma', 'Primary Peritoneal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '19628341', 'type': 'BACKGROUND', 'citation': 'Rochet N, Sterzing F, Jensen AD, Dinkel J, Herfarth KK, Schubert K, Eichbaum MH, Schneeweiss A, Sohn C, Debus J, Harms W. Intensity-modulated whole abdominal radiotherapy after surgery and carboplatin/taxane chemotherapy for advanced ovarian cancer: phase I study. Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1382-9. doi: 10.1016/j.ijrobp.2009.03.061. Epub 2009 Jul 21.'}, {'pmid': '31639066', 'type': 'DERIVED', 'citation': 'Arians N, Kieser M, Benner L, Rochet N, Schroder L, Katayama S, Herfarth K, Schubert K, Schneeweiss A, Sohn C, Lindel K, Debus J. Adjuvant intensity modulated whole-abdominal radiation therapy for high-risk patients with ovarian cancer FIGO stage III: final results of a prospective phase 2 study. Radiat Oncol. 2019 Oct 21;14(1):179. doi: 10.1186/s13014-019-1381-2.'}, {'pmid': '21276234', 'type': 'DERIVED', 'citation': 'Rochet N, Kieser M, Sterzing F, Krause S, Lindel K, Harms W, Eichbaum MH, Schneeweiss A, Sohn C, Debus J. Phase II study evaluating consolidation whole abdominal intensity-modulated radiotherapy (IMRT) in patients with advanced ovarian cancer stage FIGO III--the OVAR-IMRT-02 Study. BMC Cancer. 2011 Jan 28;11:41. doi: 10.1186/1471-2407-11-41.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this phase-II study is to assess the toxicity of consolidation intensity-modulated whole-abdominal radiotherapy using tomotherapy in patients with advanced optimally debulked stage International Federation of Gynecology and Obstetrics (FIGO) III ovarian cancer with a complete remission after adjuvant chemotherapy.\n\n36 patients will be treated to a total dose of 30 Gy in 1.5 Gy fractions. The planning target-volume includes the entire peritoneal cavity and the pelvic and para-aortal node regions. Intensity-modulated whole-abdominal radiotherapy allows an effective sparing of liver, kidneys and bone-marrow (vertebral bodies and pelvic bones).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed ovarian cancer or tube cancer or primary peritoneal carcinoma stage FIGO III\n* primary optimal debulking surgery\n* postoperative gross residual tumor ≤ 1cm ( R0, R1 oder R2 \\< 1cm situation)\n* adjuvant chemotherapy with platin and taxane\n* complete remission after chemotherapy\n* Karnofsky performance score \\> 60\n* patients \\>18 years of age\n* written informed consent\n\nExclusion Criteria:\n\n* stage FIGO I or II\n* stage III with postoperative gross residual tumor \\> 1cm\n* stage FIGO IV\n* recurrence situation\n* delayed wound healing post laparotomy\n* leucopenia \\<2000/ml before radiotherapy\n* thrombocytopenia \\<75000/ml before radiotherapy\n* clinically active renal, hepatic, cardiac, metabolic, respiratory, coagulation or hematopoietic disease\n* status post pelvic or abdominal radiotherapy\n* status post other cancer disease in the past 5 years (cervical cancer in situ, basal cell carcinoma, squamous cell carcinoma of the skin are excluded)\n* participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT01180504', 'acronym': 'OVAR-IMRT-02', 'briefTitle': 'Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Consolidation Intensity-Modulated Whole Abdominal Radiotherapy for High-Risk Patients With Ovarian Cancer Stage FIGO III', 'orgStudyIdInfo': {'id': 'OVAR-IMRT-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intensity-modulated whole-abdominal radiotherapy', 'type': 'RADIATION', 'description': 'Consolidation intensity-modulated whole-abdominal radiotherapy using helical tomotherapy to a total dose of 30 Gy in 1.5 Gy fractions'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nathalie Rochet, MD', 'role': 'CONTACT', 'email': 'nathalie.rochet@med.uni-heidelberg.de', 'phone': '0049 6221 56 8201'}, {'name': 'Juergen Debus, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Radiation Oncology, University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Nathalie Rochet, MD', 'role': 'CONTACT', 'email': 'nathalie.rochet@med.uni-heidelberg.de', 'phone': '0049 6221 56 8202'}], 'overallOfficials': [{'name': 'Andreas Schneeweiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gyneacology and Obstetrics, Unversity of Heidelberg'}, {'name': 'Juergen Debus, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, University of Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsche Krebshilfe e.V., Bonn (Germany)', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Juergen Debus / Prof., M.D., PhD', 'oldOrganization': 'Department of Radiation Oncology, University of Heidelberg'}}}}