Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-26 @ 7:22 AM
Study NCT ID:
NCT00445757
Status:
WITHDRAWN
Last Update Posted:
2012-03-20
First Post:
2007-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'slow accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-16', 'studyFirstSubmitDate': '2007-03-07', 'studyFirstSubmitQcDate': '2007-03-07', 'lastUpdatePostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose of radiation', 'timeFrame': 'DLT is assessed at 4 and 8 weeks after radiotherapy'}, {'measure': 'Radiotherapy-associated toxicity', 'timeFrame': 'DLT is assessed at 4 and 8 weeks after radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': 'follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery'}, {'measure': 'Time to local progression', 'timeFrame': 'follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery'}, {'measure': 'Time to distant failure', 'timeFrame': 'follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery'}, {'measure': 'Survival', 'timeFrame': 'follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery'}, {'measure': 'Disease-specific survival', 'timeFrame': 'follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I renal cell cancer', 'stage II renal cell cancer'], 'conditions': ['Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with kidney tumors.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of radiation in patients undergoing stereotactic radiotherapy for renal tumors.\n* Determine radiotherapy-associated toxicity in these patients.\n\nSecondary\n\n* Determine preoperative pathologic response to this regimen in these patients.\n\nOUTLINE: This is a dose-escalation study of radiotherapy.\n\n* Radiotherapy: Patients undergo stereotactic radiotherapy to 1 tumor. Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose (MTD) or upper limit is reached. The MTD is defined as the dose preceding that at which at least 2 of 4 or 3 of 8 patients experience dose-limiting toxicity (DLT). DLT is assessed at 4 and 8 weeks after radiotherapy.\n* Surgery: Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.\n\nAfter completion of study therapy, patients are followed periodically for at least 2 years.\n\nPROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Radiologically confirmed renal tumor\n\n * At least 4 cm in greatest dimension\n* No clinically, radiologically, or pathologically involved lymph nodes\n* No distant metastases\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 70-100%\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Medically eligible for tumor resection\n* No major medical condition or psychiatric illness that would preclude study compliance\n* No active connective tissue disease, such as lupus or dermatomyositis\n* No active Crohn's disease or active ulcerative colitis\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy\n* No prior abdominal or pelvic radiotherapy\n* No prior cryosurgery\n* No prior radiofrequency ablation"}, 'identificationModule': {'nctId': 'NCT00445757', 'briefTitle': 'Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors', 'orgStudyIdInfo': {'id': 'CASE5806'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': 'CASE5806', 'type': 'OTHER', 'domain': 'Case Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'conventional surgery', 'type': 'PROCEDURE', 'description': 'Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.'}, {'name': 'stereotactic radiosurgery', 'type': 'RADIATION', 'description': 'Patients undergo stereotactic radiotherapy to 1 tumor. Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose (MTD) or upper limit is reached.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Lee E. Ponsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}