Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT00821860
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
2009-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D054363', 'term': 'Solitary Fibrous Tumor, Pleural'}, {'id': 'D016066', 'term': 'Pleural Effusion, 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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D054364', 'term': 'Solitary Fibrous Tumors'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D010995', 'term': 'Pleural Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013627', 'term': 'Talc'}], 'ancestors': [{'id': 'D017633', 'term': 'Magnesium Silicates'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017640', 'term': 'Silicates'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D012824', 'term': 'Silicic Acid'}, {'id': 'D012822', 'term': 'Silicon Dioxide'}, {'id': 'D017655', 'term': 'Silicon Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-27', 'studyFirstSubmitDate': '2009-01-13', 'studyFirstSubmitQcDate': '2009-01-13', 'lastUpdatePostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival at 1 year after treatment', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Control of pleural effusion', 'timeFrame': '1 year'}, {'measure': 'Complications, including need for more surgery, persistent air leak requiring pleural intubation for > 10 days, and hospital stay for > 12 days', 'timeFrame': '1 year'}, {'measure': 'Symptoms and quality of life as assessed by the EuroQol questionnaire', 'timeFrame': '0, 1, 3, 6 12 months'}, {'measure': 'Length of hospital stay', 'timeFrame': '1 year'}, {'measure': 'Exercise tolerance', 'timeFrame': '0, 1, 3, 6 12 months'}, {'measure': 'Cost to the health service, in terms of resources used for procedures, hospital bed usage, and cost of primary and secondary care over 12 months', 'timeFrame': '0, 1, 3, 6 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['epithelial mesothelioma', 'recurrent malignant mesothelioma', 'sarcomatous mesothelioma', 'malignant pleural effusion', 'stage IA malignant mesothelioma', 'stage IB malignant mesothelioma', 'stage II malignant mesothelioma', 'stage III malignant mesothelioma', 'stage IV malignant mesothelioma'], 'conditions': ['Malignant Mesothelioma', 'Metastatic Cancer']}, 'referencesModule': {'references': [{'pmid': '24942631', 'type': 'DERIVED', 'citation': 'Rintoul RC, Ritchie AJ, Edwards JG, Waller DA, Coonar AS, Bennett M, Lovato E, Hughes V, Fox-Rushby JA, Sharples LD; MesoVATS Collaborators. Efficacy and cost of video-assisted thoracoscopic partial pleurectomy versus talc pleurodesis in patients with malignant pleural mesothelioma (MesoVATS): an open-label, randomised, controlled trial. Lancet. 2014 Sep 20;384(9948):1118-27. doi: 10.1016/S0140-6736(14)60418-9. Epub 2014 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of the chest cavity may be effective in treating pleural effusion and cause less damage to normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is not yet known which therapy is more effective in treating pleural effusion caused by malignant mesothelioma.\n\nPURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the effectiveness of video-assisted thoracoscopic cytoreductive pleurectomy vs talc pleurodesis, in terms of 1-year survival, in patients with suspected or proven malignant mesothelioma.\n\nSecondary\n\n* Compare the control of pleural effusion in these patients.\n* Compare procedure-related complications in these patients.\n* Compare the symptoms and quality of life of these patients at 3, 6, and 12 months after treatment.\n* Compare the length of hospital stay for these patients.\n* Compare the exercise tolerance of these patients at 3, 6, and 12 months after treatment.\n* Determine the cost to the health service, in terms of resources used for procedures, hospital bed usage, and cost of primary and secondary care over 12 months.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to risk (high vs low). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I (video-assisted thoracoscopic \\[VAT\\] cytoreductive pleurectomy): Patients undergo VAT cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.\n* Arm II (talc pleurodesis): Patients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results.\n\nQuality of life, complications, and resource use are assessed at baseline and at 1, 3, 6, and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Confirmed or suspected mesothelioma\n\n * Any subtype allowed\n* Pleural effusion must be present\n\nPATIENT CHARACTERISTICS:\n\n* Clinically fit and suitable for video-assisted thoracoscopic cytoreductive pleurectomy\n* Prior malignancy allowed provided it no longer requires treatment AND patient has a confirmed diagnosis of mesothelioma\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior attempted pleurodesis by any approach'}, 'identificationModule': {'nctId': 'NCT00821860', 'acronym': 'MesoVATS', 'briefTitle': 'Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Papworth Hospital NHS Foundation Trust'}, 'officialTitle': 'Prospective Randomised Controlled Trial of Video-Assisted Thoracoscopic (VAT) Cytoreductive Pleurectomy Compared to Talc Pleurodesis in Patients With Suspected or Proven Malignant Mesothelioma', 'orgStudyIdInfo': {'id': 'P00804'}, 'secondaryIdInfos': [{'id': 'PAPWORTH-MESOVATS'}, {'id': 'PAPWORTH-P00804'}, {'id': 'EU-20901'}, {'id': 'ISRCTN34321019'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients undergo video-assisted thoracoscopic cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.', 'interventionNames': ['Procedure: therapeutic videothoracoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II', 'description': 'Patients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results.', 'interventionNames': ['Other: talc', 'Procedure: therapeutic thoracoscopy']}], 'interventions': [{'name': 'talc', 'type': 'OTHER', 'description': 'Talc pleurodesis', 'armGroupLabels': ['Arm II']}, {'name': 'therapeutic thoracoscopy', 'type': 'PROCEDURE', 'description': 'Talc pleurodesis via thoracoscopy', 'armGroupLabels': ['Arm II']}, {'name': 'therapeutic videothoracoscopy', 'type': 'PROCEDURE', 'description': 'Video-assisted thoracoscopic pleurectomy', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS16 5NL', 'city': 'Basildon', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Basildon University Hospital', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'CB3 8RE', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Papworth Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'LE3 9QP', 'city': 'Leicester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Glenfield Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'SE1 9RT', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'S1O 2JF', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Hallamshire Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Robert Winter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Papworth Hospital NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Papworth Hospital NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}