Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT00354393
Status:
COMPLETED
Last Update Posted:
2025-07-15
First Post:
2006-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy With or Without Surgery & Chemoradiotherapy in Patients With Malignant Pleural Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}, {'id': 'D054363', 'term': 'Solitary Fibrous Tumor, Pleural'}], '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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2006-07-19', 'studyFirstSubmitQcDate': '2006-07-19', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Response', 'timeFrame': 'After 2-4 cycles of induction chemotherapy (28 day cycle)', 'description': 'Best response to chemotherapy after induction'}], 'secondaryOutcomes': [{'measure': 'Tolerability and toxicity', 'timeFrame': 'After 2-4 cycles of induction chemotherapy (28 day cycle)', 'description': 'Toxicity related to induction chemotherapy'}, {'measure': 'Relapse free and overall survival', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first', 'description': 'Time to relapse and overall survival'}, {'measure': 'Assess Patient Quality of Life', 'timeFrame': 'Prior to initiation of each cycle of therapy, and every 3 months after completion of therapy until death, withdrawal or loss to follow up (Average 10 years)', 'description': 'Patient Quality of Life during induction chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['localized malignant mesothelioma', 'sarcomatous mesothelioma', 'advanced malignant mesothelioma', 'epithelial mesothelioma'], 'conditions': ['Malignant Mesothelioma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinorelbine, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin may also make tumor cells more sensitive to radiation therapy. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery.\n\nPURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without surgery and chemoradiotherapy works in treating patients with malignant pleural mesothelioma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Assess the response to induction combination chemotherapy comprising methotrexate, vinorelbine ditartrate, and cisplatin in patients with previously untreated malignant pleural mesothelioma.\n\nSecondary\n\n* Assess the tolerability and toxicity of this regimen in these patients.\n* Determine relapse-free and overall survival of patients treated with induction combination chemotherapy with or without surgery and hemithoracic radiation.\n* Assess the impact of induction combination chemotherapy on operability and surgical success.\n* Evaluate the impact of these treatment regimens on quality of life.\n\nOUTLINE:\n\n* Induction chemotherapy: Patients receive MVP chemotherapy comprising cisplatin IV over 30-60 minutes on day 1 and vinorelbine ditartrate IV over 5-10 minutes and methotrexate IV over 5-30 minutes on days 8, 15, and 22. Treatment repeats every 28 days for 2 courses. Patients with unresectable disease may receive up to 2 additional courses of induction chemotherapy. Patients requiring palliative radiotherapy or who have progressive disease are removed from the study. Patients with resectable disease or sarcomatoid histology and T1-3, N1-2 disease with a complete or partial response to induction chemotherapy proceed to surgery.\n* Surgery: Patients with extensive disease undergo palliative debulking pleurectomy and decortication and then are taken off study. All other patients undergo a thoracotomy with an extrapleural pneumonectomy and then proceed to chemoradiotherapy.\n* Chemoradiotherapy: Beginning 6-10 weeks after surgery, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients also receive cisplatin IV over 30-60 minutes on days 1 and 22. Patients with responding disease proceed to adjuvant chemotherapy.\n* Adjuvant chemotherapy: Patients receive 2 additional courses of MVP chemotherapy as above.\n\nQuality of life is assessed at baseline, after each course of induction chemotherapy, before surgery, and then every 3 months thereafter.\n\nAfter completion of study therapy, patients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed malignant pleural mesothelioma\n\n * Amenable to aggressive surgical resection, if deemed resectable\n\n * Patients with potentially resectable disease must have undergone mediastinoscopy to establish surgical stage\n\n * Resectable disease is defined as any of the following:\n\n * Epithelioid, mixed histology, or histology not otherwise specified with clinical stage I-III (T1-3, N0-2, M0) disease\n * Sarcomatoid histology with clinical stage I-III (T1-3, N0) disease\n * Intraperitoneal extension, contralateral thoracic extension, or distant metastases are eligible, but considered unresectable\n\n * Disease considered unresectable by any medical reason or if surgery was declined\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-1\n* WBC ≥ 3,000/mm³\n* Platelet count \\> 100,000/mm³\n* Creatinine ≤ 1.7 mg/dL\n* Alkaline phosphatase \\< 2 times normal\n* AST \\< 2 times normal\n* Albumin \\> 3 g/dL\n* Bilirubin \\< 2.0 mg/dL\n* Patients must be available for and compliant with adequate long-term follow-up\n* Not pregnant\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Patients with resectable disease must have adequate pulmonary function to undergo surgery and radiotherapy\n* No other active malignancies\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior surgical resection, radiation therapy, chemotherapy, or immunotherapy for this cancer'}, 'identificationModule': {'nctId': 'NCT00354393', 'briefTitle': 'Combination Chemotherapy With or Without Surgery & Chemoradiotherapy in Patients With Malignant Pleural Mesothelioma', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma', 'orgStudyIdInfo': {'id': 'CASE-CCF-IRB-5179'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': 'CASE-CCF-IRB-5179', 'type': 'OTHER', 'domain': 'Internal IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Induction Combination Chemotherapy', 'description': "Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses.\n\nPatients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology \\& T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery.\n\nSurgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication \\& are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy \\& proceed to chemoradiotherapy.\n\nChemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 \\& 22. Patients w/ responding disease proceed to adjuvant chemotherapy.\n\nAdjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy", 'interventionNames': ['Drug: Cisplatin', 'Drug: Methotrexate', 'Drug: Vinorelbine ditartrate', 'Procedure: Adjuvant therapy', 'Procedure: Conventional surgery', 'Procedure: Neoadjuvant Therapy', 'Radiation: 3-dimensional conformal radiation therapy', 'Radiation: Intensity-modulated radiation therapy']}], 'interventions': [{'name': 'Cisplatin', 'type': 'DRUG', 'armGroupLabels': ['Induction Combination Chemotherapy']}, {'name': 'Methotrexate', 'type': 'DRUG', 'armGroupLabels': ['Induction Combination Chemotherapy']}, {'name': 'Vinorelbine ditartrate', 'type': 'DRUG', 'armGroupLabels': ['Induction Combination Chemotherapy']}, {'name': 'Adjuvant therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['Induction Combination Chemotherapy']}, {'name': 'Conventional surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Induction Combination Chemotherapy']}, {'name': 'Neoadjuvant Therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['Induction Combination Chemotherapy']}, {'name': '3-dimensional conformal radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Induction Combination Chemotherapy']}, {'name': 'Intensity-modulated radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Induction Combination Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'David J. Adelstein, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Case Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Shared on Physician Data Query'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}