Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT03618706
Status:
UNKNOWN
Last Update Posted:
2018-08-07
First Post:
2018-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent 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': 107}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2023-05-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year progression-free survival (PFS)', 'timeFrame': '2 years after radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Local control of recurred lesions', 'timeFrame': '2 years after radiotherapy'}, {'measure': 'Any other new recurrence events', 'timeFrame': '2 years after radiotherapy'}, {'measure': 'Radiotherapy-related complications', 'timeFrame': '2 years after radiotherapy'}, {'measure': 'Chemotherapy-free interval (The interval to delay the need for a new chemotherapy regimen for disease progression)', 'timeFrame': '2 years after radiotherapy', 'description': 'It means the interval between the last date performing the previous chemotherapy (before the start of involved-field radiotherapy) and the first date performing the new regimen of chemotherapy (for the disease failures after the involve-field radiotherapy). We want to measure this interval because we want to check the capability of involved-field radiotherapy to delay the need for the new regimen of chemotherapy for the progressive diseases.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effect of involved-field radiotherapy for recurrent ovarian cancer after primary standard treatment. We will investigate whether the addition of involved-field RT improves 2-year PFS in those patients than that of historical data (only with other standard salvage treatments as systemic chemotherapy ± maximum tumor resection).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed ovarian carcinoma\n* Patients who received "standard treatment" for each stage as a primary treatment\n* No. of recurrent lesions:\n\nIf, all in lung, or intra-abdominal or pelvis organs - ≤ 5 If, any in liver, bone, or spinal cord - ≤ 2\n\n* Size of recurrent lesions ≤5 cm\n* All recurrent lesions are available for involved-field radiotherapy\n* Within 60 days before enrollment:\n* Absolute neutrophil count ANC ≥ 500 / mm3\n* Platelet ≥ 50,000 / mm3\n* Hb ≥ 8.0 g / dl\n* Good performance status (ECOG 0-1)\n\nExclusion Criteria:\n\n* Brain metastasis\n* Diffuse peritoneal carcinomatosis\n* Malignant pleural effusion\n* History of previous salvage radiotherapy for recurrent lesions\n* History of other malignancy or severe/unstable medical condition'}, 'identificationModule': {'nctId': 'NCT03618706', 'briefTitle': 'Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'A Phase II Trial of Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer', 'orgStudyIdInfo': {'id': '4-2018-0299'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'involved-field RT + standard salvage treatment', 'description': 'Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer', 'interventionNames': ['Radiation: Involved-field radiotherapy']}], 'interventions': [{'name': 'Involved-field radiotherapy', 'type': 'RADIATION', 'description': "After the diagnosis of recurrences, patients will receive involved-field radiotherapy (gross tumor volume + margin) with any radiation dose scheme (≥45 Gy Biological Equivalent dose) as physician's discretion.", 'armGroupLabels': ['involved-field RT + standard salvage treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Korea', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'YongBae Kim, MD', 'role': 'CONTACT', 'email': 'ybkim3@yuhs.ac', 'phone': '82-10-6256-2592'}], 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yong Bae Kim, MD, PhD', 'role': 'CONTACT', 'email': 'ybkim3@yuhs.ac', 'phone': '82-2228-8095'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}