Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-03 @ 7:59 PM
Study NCT ID:
NCT01847495
Status:
WITHDRAWN
Last Update Posted:
2024-10-04
First Post:
2013-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no patients enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2013-04-12', 'studyFirstSubmitQcDate': '2013-05-02', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events related to toxicities from concurrent SBRT and irinotecan', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Tumor response rate', 'timeFrame': '3 years'}, {'measure': 'Progression free survival', 'timeFrame': '3 years'}, {'measure': 'Overall survival', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stage IV Colorectal Carcinoma', 'Liver metastasis', 'Cyberknife', 'Stereotactic Body Radiotherapy', 'SBRT', 'Irinotecan HCl', 'CPT-11'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of CyberKnife stereotactic body radiotherapy in combination with irinotecan chemotherapy in patients with colon or rectal cancer that has spread to the liver.\n\nConventional radiation therapy has a limited role in the treatment of patients with liver metastases because the radiation doses are limited by liver toxicity. The CyberKnife system is a type of radiation machine that precisely focuses large doses of x-rays on the tumor, so that injury from radiation to the nearby normal tissue will be minimal. It is approved by the U.S. Food and Drug Administration to treat tumors, lesions and conditions anywhere in the body when radiation therapy is required. While the device is no longer classified as "investigational", the best treatment dose and times are still being evaluated.\n\nChemotherapy delivered with radiation therapy can increase the effectiveness of treatment, and may allow for a lower dose of radiation therapy to be utilized, thereby limiting negative side effects.\n\nIn this study, patients will receive Cyberknife radiosurgery directed to liver metastasis for 3-5 treatments, given every other day. Irinotecan 40mg/m2 will be administered intravenously daily for 3-5 days (5 treatments within 10 elapsed days), and prior to radiation therapy. Patients will have follow-up visits at months 1,2,4,6,9,12,15,18, 24, 30, 36, and every 6 months thereafter for 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Age\\>18 years\n* Histologically confirmed primary colorectal cancer\n* Stage IV colorectal cancer with \\</= 3 metastases, up to 5cm in size.\n* CT scan or MRI of the abdomen with contrast, 60days prior to enrollment\n* If patient is allergic to contrast, imaging without contrast is acceptable\n* Positron-Emission Tomography 60 days prior to enrollment\n* No additional sites of metastasis at the time of protocol enrollment. History of other sites of metastasis that are currently controlled are acceptable.\n* No malignant ascites\n* At least 4 weeks from any chemotherapy\n* No prior liver radiation therapy\n* ECOG performance status 0-1\n* Life expectancy\\>3months\n* Laboratory evaluations completed 60 days prior to treatment including CMP, CBC with differential, liver function test, and prothrombin time.'}, 'identificationModule': {'nctId': 'NCT01847495', 'briefTitle': 'Evaluation of Low-dose Irinotecan and Cyberknife® SBRT to Treat Colorectal Cancer With Limited Liver Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Prospective Evaluation of Low-dose Irinotecan and Cyberknife® Stereotactic Body Radiotherapy in the Treatment of Patients With Colorectal Cancer and Limited Liver Metastasis', 'orgStudyIdInfo': {'id': '5443'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-Dose Irinotecan & CyberKnife SBRT', 'description': 'Irinotecan 40mg/m2 x 3-5 days + CyberKnife SBRT 45-60Gy x 3-5 fractions', 'interventionNames': ['Drug: Irinotecan', 'Radiation: CyberKnife']}], 'interventions': [{'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['Camptosar', 'Irinotecan Hydrochloride', 'Irinotecan HCl', 'CPT-11'], 'description': '40mg/m2 x 3-5 days', 'armGroupLabels': ['Low-Dose Irinotecan & CyberKnife SBRT']}, {'name': 'CyberKnife', 'type': 'RADIATION', 'otherNames': ['Stereotactic Radiosurgery'], 'description': '45-60 Gy for 3-5 days CyberKnife SBRT to liver metastasis within 10 elapsed days. Irinotecan will be administered on the same day, prior to SBRT.', 'armGroupLabels': ['Low-Dose Irinotecan & CyberKnife SBRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Lutheran General Hospital', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}], 'overallOfficials': [{'name': 'Arica Hirsch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Advocate Lutheran General Hospital'}, {'name': 'James Ruffer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Advocate Lutheran General Hospital'}, {'name': 'Jacob Bitran, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Advocate Lutheran General Hospital'}, {'name': 'Edward S James, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Advocate Lutheran General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}