Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-08 @ 4:42 AM
Study NCT ID:
NCT02672033
Status:
TERMINATED
Last Update Posted:
2020-07-24
First Post:
2015-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients With Malignant Pleural Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}], 'ancestors': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069473', 'term': 'Radiation Dose Hypofractionation'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D019583', 'term': 'Dose Fractionation, Radiation'}, {'id': 'D011879', 'term': 'Radiotherapy Dosage'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'percylee@mednet.ucla.edu', 'phone': '310 825-9771', 'title': 'Dr. Percy Lee', 'organization': 'Jonsson Comprehensieve Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Due to the rarity of malignant pleural mesothelioma only two patients were enrolled and treated. There number as insufficient for any analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from 10/2015 until 4/2018, 30 months.', 'description': "Dose limiting toxicity (DLT) defined as any treatment-related grade 3 or higher toxicity in the following categories: respiratory, upper GI, and cardiac. Also, any other grade 4 or 5 toxicity attributed to the therapy constitutes DLT. All AE's and SAE's, with grade and attribution were submitted to our DSMB as part of our quarterly summary reports. Serious adverse events were also reported individually to the DSMB and, where required, to our UCLA IRB within 2-10 days of awareness.", 'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)', 'description': 'Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.\n\nHypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nIntensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo pleurectomy/decortication', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Death', 'notes': 'Expired from respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ability to Accrue Sufficient Patients to Draw Conclusions About Endpoints in a Timely and Expedient Manner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)', 'description': 'Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.\n\nHypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nIntensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo pleurectomy/decortication'}], 'timeFrame': 'Up to 1 year', 'description': 'No data displayed because Outcome Measure has zero total participants analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected'}, {'type': 'PRIMARY', 'title': 'Incidence of Acute and Subacute Toxicity Defined as Grade 4 or 5 Adverse Events as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)', 'description': 'Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.\n\nHypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nIntensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo pleurectomy/decortication'}], 'timeFrame': 'Up to 3 months', 'description': 'No data displayed because Outcome Measure has zero total participants analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected'}, {'type': 'PRIMARY', 'title': 'Incidence of Chronic Toxicity as Assessed by the NCI CTCAE Version 4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)', 'description': 'Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.\n\nHypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nIntensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo pleurectomy/decortication'}], 'timeFrame': 'Up to 5 years post-treatment', 'description': 'No data displayed because Outcome Measure has zero total participants analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected'}, {'type': 'SECONDARY', 'title': 'Disease Specific Survival (DSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)', 'description': 'Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.\n\nHypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nIntensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo pleurectomy/decortication'}], 'timeFrame': 'Up to 5 years post-treatment', 'description': 'Cumulative incidence approach will be used to estimate DSS. No data displayed because Outcome Measure has zero total participants analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}, {'type': 'SECONDARY', 'title': 'Local Control (LC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)', 'description': 'Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.\n\nHypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nIntensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo pleurectomy/decortication'}], 'timeFrame': 'Up to 5 years post-treatment', 'description': 'Cumulative incidence approach will be used to estimate the local failure rates. No data displayed because Outcome Measure has zero total participants analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)', 'description': 'Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.\n\nHypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nIntensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo pleurectomy/decortication'}], 'timeFrame': 'Up to 5 years post-treatment', 'description': 'No data displayed because Outcome Measure has zero total participants analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected'}, {'type': 'SECONDARY', 'title': 'Pathologic Complete Response Rate (pCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)', 'description': 'Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.\n\nHypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nIntensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo pleurectomy/decortication'}], 'timeFrame': 'Up to 5 years post-treatment', 'description': 'No data displayed because Outcome Measure has zero total participants analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)', 'description': 'Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.\n\nHypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nIntensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo pleurectomy/decortication'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From 10/2015 to 04/2018, 2 subjects were consented into the trial.', 'preAssignmentDetails': 'Eligibility screening by the Jonsson Comprehensive Cancer Center Data Safety Monitoring Board. Subjects undergo 5 fractions of hypofractionationated Intensity Modulated Radiation Therapy (IMRT) over 1 week with simultaneous integrated boost to gross disease.Subjects then undergo pleurectomy/decortication within 14 days after completion of IMRT.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)', 'description': 'Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.\n\nHypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nIntensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT\n\nLaboratory Biomarker Analysis: Correlative studies\n\nTherapeutic Conventional Surgery: Undergo pleurectomy/decortication'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'title': '63 Years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '69 Years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2015-11-02', 'resultsFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2016-01-29', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-05', 'studyFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to Accrue Sufficient Patients to Draw Conclusions About Endpoints in a Timely and Expedient Manner', 'timeFrame': 'Up to 1 year', 'description': 'No data displayed because Outcome Measure has zero total participants analyzed.'}, {'measure': 'Incidence of Acute and Subacute Toxicity Defined as Grade 4 or 5 Adverse Events as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0', 'timeFrame': 'Up to 3 months', 'description': 'No data displayed because Outcome Measure has zero total participants analyzed.'}, {'measure': 'Incidence of Chronic Toxicity as Assessed by the NCI CTCAE Version 4.0', 'timeFrame': 'Up to 5 years post-treatment', 'description': 'No data displayed because Outcome Measure has zero total participants analyzed.'}], 'secondaryOutcomes': [{'measure': 'Disease Specific Survival (DSS)', 'timeFrame': 'Up to 5 years post-treatment', 'description': 'Cumulative incidence approach will be used to estimate DSS. No data displayed because Outcome Measure has zero total participants analyzed.'}, {'measure': 'Local Control (LC)', 'timeFrame': 'Up to 5 years post-treatment', 'description': 'Cumulative incidence approach will be used to estimate the local failure rates. No data displayed because Outcome Measure has zero total participants analyzed.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 5 years post-treatment', 'description': 'No data displayed because Outcome Measure has zero total participants analyzed.'}, {'measure': 'Pathologic Complete Response Rate (pCR)', 'timeFrame': 'Up to 5 years post-treatment', 'description': 'No data displayed because Outcome Measure has zero total participants analyzed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pleural Epithelioid Mesothelioma', 'Pleural Malignant Mesothelioma']}, 'descriptionModule': {'briefSummary': 'This pilot phase 0 trial studies accelerated hypofractionated radiation therapy immediately before surgery in treating patients with malignant pleural mesothelioma (cancer in the thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity). Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Hypofractionated radiation therapy is a type of radiation therapy in which the total prescribed dose of radiation is divided into fewer but larger doses as compared to conventional radiation therapy. Giving accelerated hypofractionated radiation therapy immediately before surgery may improve survival, and may also reduce side effects experienced by patients with pleural mesothelioma.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the feasibility and toxicity (both acute and chronic) of accelerated hypofractionated neoadjuvant helical intensity modulated radiation therapy prior to pleurectomy/decortication for malignant pleural mesothelioma.\n\nSECONDARY OBJECTIVES:\n\nI. To determine the pathologic complete response rate (pCR). II. To determine the tumor local control rate (LC). III. To determine the malignant pleural mesothelioma disease specific survival (DSS).\n\nIV. To determine the overall survival (OS). V. To assess transforming growth factor beta (TGF-B), interleukin (IL)-1, and IL-6 levels as predictive biomarkers for treatment induced tissue injury.\n\nVI. To assess the changes in the postoperative pleural immunological milieu in terms of chemo- and cytokine expression.\n\nOUTLINE:\n\nPatients undergo 5 fractions of accelerated hypofractionated intensity-modulated radiation therapy (IMRT) over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.\n\nAfter completion of study treatment, patients are followed up at 6 weeks, and then every 3 months for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed epithelioid predominantly (\\> 70%) subtype malignant pleural mesothelioma\n* Patient must have been evaluated by a University of California Los Angeles (UCLA) thoracic surgeon, and deemed medically and technically suitable for a pleurectomy/decortication procedure\n* Karnofsky performance status (KPS) \\>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2\n* If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study\n\nExclusion Criteria:\n\n* Patients who have previously received therapeutic radiation therapy to the chest\n* Active systemic, pulmonary, or pericardial infection\n* Use of chemotherapy within 4 weeks of the planned start of radiation therapy\n* Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study\n* Refusal to sign the informed consent\n* Patients who are participating in a concurrent treatment protocol'}, 'identificationModule': {'nctId': 'NCT02672033', 'briefTitle': 'Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients With Malignant Pleural Mesothelioma', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'Neoadjuvant Accelerated Hypofractionated Radiation Therapy Immediately Prior to Radical Pleurectomy/Decortication for Malignant Pleural Mesothelioma: A Pilot Study', 'orgStudyIdInfo': {'id': '15-000487'}, 'secondaryIdInfos': [{'id': 'NCI-2015-01736', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'JCCCID552', 'type': 'OTHER', 'domain': 'Jonsson Comprehensive Cancer Center'}, {'id': '15-000487', 'type': 'OTHER', 'domain': 'UCLA / Jonsson Comprehensive Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (hypofractionated IMRT, pleurectomy/decortication)', 'description': 'Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.', 'interventionNames': ['Radiation: Hypofractionated Radiation Therapy', 'Radiation: Intensity-Modulated Radiation Therapy', 'Other: Laboratory Biomarker Analysis', 'Procedure: Therapeutic Conventional Surgery']}], 'interventions': [{'name': 'Hypofractionated Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Hypofractionated Radiotherapy', 'hypofractionation'], 'description': 'Undergo accelerated hypofractionated IMRT', 'armGroupLabels': ['Treatment (hypofractionated IMRT, pleurectomy/decortication)']}, {'name': 'Intensity-Modulated Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['IMRT', 'Intensity Modulated RT', 'Intensity-Modulated Radiotherapy'], 'description': 'Undergo accelerated hypofractionated IMRT', 'armGroupLabels': ['Treatment (hypofractionated IMRT, pleurectomy/decortication)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (hypofractionated IMRT, pleurectomy/decortication)']}, {'name': 'Therapeutic Conventional Surgery', 'type': 'PROCEDURE', 'description': 'Undergo pleurectomy/decortication', 'armGroupLabels': ['Treatment (hypofractionated IMRT, pleurectomy/decortication)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA / Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Percy Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA / Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}