Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-01-03 @ 11:28 PM
Study NCT ID:
NCT00387868
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2006-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Treatment of Patients With High Risk Thymoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013945', 'term': 'Thymoma'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013953', 'term': 'Thymus Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-08', 'studyFirstSubmitDate': '2006-10-11', 'studyFirstSubmitQcDate': '2006-10-11', 'lastUpdatePostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the complete pathologic response rate to peroperative cisplatin and etoposide given concurrently with radiation in patients with thymoma thought to be at high risk for recurrence', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Radiographic response to preoperative chemoradiotherapy by comparing pre and post treatment CT scans.', 'timeFrame': '16 weeks'}, {'measure': 'Rate of complete resection following preoperative chemoradiotherapy as determined by pathologic examination of the specimen(s).', 'timeFrame': '1-5 weeks'}, {'measure': 'Toxicities throughout the study treatment.', 'timeFrame': '5 years'}, {'measure': 'The role of PET in predicting resectability, Masaoka stage and histologic type, as well as the response to preoperative chemoradiotherapy by comparing pre and post treatment PET scans', 'timeFrame': '10 years'}, {'measure': 'Immunohistochemical assessment of relevant markers before and after chemoradiation (EGFR, p53,and Ki-67).', 'timeFrame': '10-12 years'}, {'measure': 'Blood-based correlative studies: genetic polymorphisms (EGFR, DNA repair, inflammatory gene pathways) and serologic analysis (EGFR, VEGF, bFGF, pro-MMP2 levels)', 'timeFrame': '8-10 years'}, {'measure': 'Recurrence rates and failure patterns following the treatment regimen.', 'timeFrame': '5-7 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Thymoma', 'Thymic carcinoma', 'Preoperative chemotherapy and radiation', 'Response rate'], 'conditions': ['Thymoma']}, 'referencesModule': {'references': [{'pmid': '24139613', 'type': 'DERIVED', 'citation': 'Korst RJ, Bezjak A, Blackmon S, Choi N, Fidias P, Liu G, Marx A, Wright C, Mock S, Rutledge JR, Keshavjee S. Neoadjuvant chemoradiotherapy for locally advanced thymic tumors: a phase II, multi-institutional clinical trial. J Thorac Cardiovasc Surg. 2014 Jan;147(1):36-44, 46.e1. doi: 10.1016/j.jtcvs.2013.08.061. Epub 2013 Oct 15.'}, {'pmid': '18222230', 'type': 'DERIVED', 'citation': 'Wright CD, Choi NC, Wain JC, Mathisen DJ, Lynch TJ, Fidias P. Induction chemoradiotherapy followed by resection for locally advanced Masaoka stage III and IVA thymic tumors. Ann Thorac Surg. 2008 Feb;85(2):385-9. doi: 10.1016/j.athoracsur.2007.08.051.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase II study for patients with thymoma or thymic carcinoma thought to be at significant risk for recurrence following surgical removal. This study involves the use of combined chemotherapy and radiation therapy prior to surgery, in hopes of increasing the chances of complete resection. The chemoradiotherapy protocol is one which has been used extensively for other diseases, and the side effects are therefore well-documented. Patients with thymomas thought to be at significant risk for recurrence (by x-ray and pathology criteria) will be allowed to participate, and will undergo combined chemotherapy with radiation to the chest followed by surgical removal of the tumor and postoperative chemotherapy. The main outcome measured will be the rate of pathological complete response (e.g. no active tumor in the resected specimen) to the preoperative treatment. Patients will receive postoperative treatment based on surgical and pathologic criteria.', 'detailedDescription': "Past experience has suggested that the ability to completely remove the thymoma using surgery is important in preventing recurrence. Strategies which would help the surgeon's ability to completely remove the tumor therefore need to be investigated.\n\nThis study represents a multi-institutional, phase II pilot trial of preoperative chemoradiotherapy followed by surgical resection and postoperative chemotherapy for patients with invasive thymoma or thymic carcinoma at significant risk for recurrence. We hypothesize that this strategy will be well-tolerated and produce response and resectability rates exceeding those previously published involving surgical resection alone, or preoperative chemotherapy followed by surgery. Patients with locally advanced thymoma, based on radiographic and biopsy criteria, will undergo pretreatment computed tomography (CT) scan and positron emission tomography (PET) followed by concurrent (simultaneous) chemotherapy (cisplatin and etoposide) and radiation. After this therapy, patients will be reassessed using computed tomography (CT) and PET, and undergo surgical resection of their tumors. Following resection, patients will be either observed, or treated with postoperative chemotherapy, or chemotherapy and radiation. Correlative genomic, serologic and pathologic studies will also be performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy-proven thymoma or thymic carcinoma.\n* Invasive thymoma determined by specific radiographic criteria determined by CT scan.\n* Acceptable kidney, liver, bone marrow, and respiratory functions.\n* Karnofsy performance status greater than 80%.\n* Patients must have a CT of the chest with IV contrast within 60 days of enrollment.\n* Tumors larger than 8cm in greatest diameter on CT scan.\n* For tumors 5-8cm in greatest diameter on CT scan, one or more of the following radiographic criteria must also be present on IV contrast CT Scan:\n* Multifocal calcification\n* Heterogeneous appearance\n* Irregular of scalloped borders\n* Obvious great vessel invasion or encirclement\n\nExclusion Criteria:\n\n* Considered unable to medically tolerate surgical resection at the time of initial presentation.\n* Radiographic evidence of stage IVA thymoma.\n* Pretreatment biopsy showing WHO type A thymoma unless obvious great vessel invasion/encirclement is present on CT scan.\n* Previous radiation therapy to the chest which would preclude the administration of radiation.\n* Patents receiving other investigational drugs.'}, 'identificationModule': {'nctId': 'NCT00387868', 'briefTitle': 'Preoperative Treatment of Patients With High Risk Thymoma', 'nctIdAliases': ['NCT00509522'], 'organization': {'class': 'OTHER', 'fullName': 'Valley Health System'}, 'officialTitle': 'Phase II Study of Trimodality Therapy for Patients With Thymoma or Thymic Carcinoma at Significant Risk for Recurrence', 'orgStudyIdInfo': {'id': 'VHS07.0006a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Registration', 'description': 'Cisplatin, Etoposide \\& concurrent radiotherapy', 'interventionNames': ['Drug: cisplatin and etoposide', 'Radiation: Concurrent Radiotherapy']}, {'type': 'OTHER', 'label': 'Surgical Resection', 'description': 'No distant Progression post Registration Arm', 'interventionNames': ['Procedure: Surgical Resection']}, {'type': 'OTHER', 'label': 'Post Resection', 'description': 'Assessment post surgical procedure to determine if at higher risk of recurrence or if complete resection could not be achieved.', 'interventionNames': ['Drug: cisplatin and etoposide']}], 'interventions': [{'name': 'cisplatin and etoposide', 'type': 'DRUG', 'description': 'Cisplatin: 50mg/m2 - administered on days 1,8,29\\&36 Etoposide: 50 mg/m2 - administered on days 1-5 \\& 29-33', 'armGroupLabels': ['Post Resection', 'Registration']}, {'name': 'Surgical Resection', 'type': 'PROCEDURE', 'description': 'Resection will take place 4-8 weeks after completion of radiotherapy.', 'armGroupLabels': ['Surgical Resection']}, {'name': 'Concurrent Radiotherapy', 'type': 'RADIATION', 'description': 'Preoperative External Beam Radiotherapy', 'armGroupLabels': ['Registration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07450', 'city': 'Ridgewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Valley Health System - The Valley Hospital', 'geoPoint': {'lat': 40.97926, 'lon': -74.11653}}, {'zip': 'M5G2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Robert Korst, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Valley Health Systems/ The Valley Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valley Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}