Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-30 @ 4:44 AM
Study NCT ID:
NCT00707161
Status:
TERMINATED
Last Update Posted:
2017-03-31
First Post:
2008-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radiation Therapy and Concurrent Cisplatin Chemotherapy for Locally Advanced or Metastatic Malignant Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dennis.shrieve@hci.utah.edu', 'phone': '801-581-8793', 'title': 'Dennis Shrieve, MD', 'organization': 'Huntsman Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination due to low enrollment.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm (Radiation Therapy & Cisplatin)', 'description': 'Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rate of Melanoma Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm (Radiation & Cisplatin)', 'description': 'Group of participants receiving Radiation and Cisplatin.'}], 'timeFrame': '2005-2010', 'description': 'Response rate of melanoma lesions was measured after treated with the trial agent.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated. Analysis not conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm (Radiation Therapy & Cisplatin)', 'description': 'All patients will receive Radiation Therapy and Cisplatin for their melanoma. If appropriate patients will have surgical resection for residual or recurrent melanoma following chemoradiation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '3 deceased (1-Huntsman Cancer Institute, 2- LDS Hospital).', 'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm (Radiation Therapy & Cisplatin)', 'description': 'Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'spread': '7.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'discontinued due to low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2008-06-26', 'resultsFirstSubmitDate': '2011-04-20', 'studyFirstSubmitQcDate': '2008-06-27', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-03-06', 'studyFirstPostDateStruct': {'date': '2008-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rate of Melanoma Lesions', 'timeFrame': '2005-2010', 'description': 'Response rate of melanoma lesions was measured after treated with the trial agent.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cancer', 'Melanoma']}, 'descriptionModule': {'briefSummary': 'The study is a prospective phase II trial of radiation therapy concurrent with cisplatin chemotherapy in the treatment of locally advanced or metastatic melanoma in patients who are deemed to require radiation therapy by treating physicians for purposes of local control or palliation. Eligibility criteria include pathologically confirmed melanoma. Patients will undergo radiation therapy (20 treatments of 2.5 Gy for a total of 50 Gy) concurrent with cisplatin chemotherapy.', 'detailedDescription': "This is a phase II, prospective trial designed to determine the response rate achieved with cisplatin delivered concurrent with radiation therapy in locally advanced or metastatic melanoma.\n\nRadiation therapy will be delivered concurrent with cisplatin chemotherapy as outlined in table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20 treatments). Cisplatin dose will be 100 mg/m2 given i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.\n\nSurgical resection of residual (or recurrent) melanoma for cure or for palliation may be performed following chemoradiation if deemed appropriate by the treating physicians (surgical resection may be planned following pre-operative chemoradiation or may be performed for salvage due to inadequate response to chemoradiation or for relapse following chemoradiation). Surgical resection will not be performed until at least 4 weeks following chemoradiation (unless deemed emergent by the treating physicians).\n\nIf the patient's tumor has inadequate response to chemoradiation then salvage therapies can be used as deemed appropriate by the treating physicians. In order to allow adequate response to radiation therapy, salvage therapies will not be utilized until at least 4 weeks following chemoradiation unless deemed emergent by the treating physicians."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Signed study-specific consent form prior to registration.\n* Pathologically confirmed malignant melanoma.\n* Measurable melanoma lesion deemed to require radiation by treating physicians for purposes of local control or palliation. The lesion may be the primary melanoma, a nodal metastasis, or a distant metastasis. Recurrent lesions are allowed.\n* Lesion has to be measurable clinically or radiographically in 2 dimensions.\n* Karnofsky Performance Scale (KPS) \\> 70.\n* Laboratory values\n\n * White blood cells (WBC) \\> 3000/mm3\n * Absolute granulocyte count \\> 1,500\n * Platelets \\> 100,000/mm3\n * Total bilirubin \\< 2.0 x institutional upper limit of normal\n * AST or ALT (aminotransferase/alanine aminotransferase) \\< 2.5 x institutional upper limit of normal\n * Serum calcium \\< 1.3 x institutional upper limit of normal\n * Serum creatinine \\< 1.5 mg/dL or Creatinine clearance \\> 50 cc/min,calculated as follows: CCr = 0.85 x (140-age) x (weight in kg) 72 x serum creatinine in mg/dL\n\nExclusion criteria:\n\n* Systemic therapy for malignant melanoma within one month preceding trial enrollment.\n* Prior irradiation to the planned field.\n* Concomitant chemotherapy (in addition to cisplatin) or biologic therapy is allowed.\n* Significant infection or other co-existent medical condition which would prevent the use of full dose chemotherapy.\n* Pre-existing sensory neuropathy (CTC 3.0 ≥ Grade II)\n* Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT00707161', 'briefTitle': 'Radiation Therapy and Concurrent Cisplatin Chemotherapy for Locally Advanced or Metastatic Malignant Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'A Prospective Phase II Study of Radiation Therapy and Concurrent Cisplatin Chemotherapy in the Treatment of Locally Advanced or Metastatic Malignant Melanoma', 'orgStudyIdInfo': {'id': 'HCI15461'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All participants', 'interventionNames': ['Radiation: Radiation Therapy', 'Drug: Cisplatin', 'Procedure: Surgical resection']}], 'interventions': [{'name': 'Radiation Therapy', 'type': 'RADIATION', 'description': 'Radiation therapy will be delivered concurrent with cisplatin chemotherapy as outlined in table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20 treatments).', 'armGroupLabels': ['All participants']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['chemotherapy'], 'description': 'Cisplatin dose will be 100 mg/m2 given i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.', 'armGroupLabels': ['All participants']}, {'name': 'Surgical resection', 'type': 'PROCEDURE', 'otherNames': ['surgery'], 'description': 'Surgical resection of residual (or recurrent) melanoma for cure or for palliation may be performed following chemoradiation if deemed appropriate by the treating physicians (surgical resection may be planned following pre-operative chemoradiation or may be performed for salvage due to inadequate response to chemoradiation or for relapse following chemoradiation). Surgical resection will not be performed until at least 4 weeks following chemoradiation (unless deemed emergent by the treating physicians).', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84143', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'LDS Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Dennis Shrieve, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huntsman Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}