- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00387868
Preoperative Treatment of Patients With High Risk Thymoma
Phase II Study of Trimodality Therapy for Patients With Thymoma or Thymic Carcinoma at Significant Risk for Recurrence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
This 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G2C4
- University of Toronto
-
-
-
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New Jersey
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Ridgewood, New Jersey, United States, 07450
- Valley Health System - The Valley Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Biopsy-proven thymoma or thymic carcinoma.
- Invasive thymoma determined by specific radiographic criteria determined by CT scan.
- Acceptable kidney, liver, bone marrow, and respiratory functions.
- Karnofsy performance status greater than 80%.
- Patients must have a CT of the chest with IV contrast within 60 days of enrollment.
- Tumors larger than 8cm in greatest diameter on CT scan.
- 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:
- Multifocal calcification
- Heterogeneous appearance
- Irregular of scalloped borders
- Obvious great vessel invasion or encirclement
Exclusion Criteria:
- Considered unable to medically tolerate surgical resection at the time of initial presentation.
- Radiographic evidence of stage IVA thymoma.
- Pretreatment biopsy showing WHO type A thymoma unless obvious great vessel invasion/encirclement is present on CT scan.
- Previous radiation therapy to the chest which would preclude the administration of radiation.
- Patents receiving other investigational drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Registration
Cisplatin, Etoposide & concurrent radiotherapy
|
Cisplatin: 50mg/m2 - administered on days 1,8,29&36 Etoposide: 50 mg/m2 - administered on days 1-5 & 29-33
Preoperative External Beam Radiotherapy
|
Other: Surgical Resection
No distant Progression post Registration Arm
|
Resection will take place 4-8 weeks after completion of radiotherapy.
|
Other: Post Resection
Assessment post surgical procedure to determine if at higher risk of recurrence or if complete resection could not be achieved.
|
Cisplatin: 50mg/m2 - administered on days 1,8,29&36 Etoposide: 50 mg/m2 - administered on days 1-5 & 29-33
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Radiographic response to preoperative chemoradiotherapy by comparing pre and post treatment CT scans.
Time Frame: 16 weeks
|
16 weeks
|
Rate of complete resection following preoperative chemoradiotherapy as determined by pathologic examination of the specimen(s).
Time Frame: 1-5 weeks
|
1-5 weeks
|
Toxicities throughout the study treatment.
Time Frame: 5 years
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5 years
|
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
Time Frame: 10 years
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10 years
|
Immunohistochemical assessment of relevant markers before and after chemoradiation (EGFR, p53,and Ki-67).
Time Frame: 10-12 years
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10-12 years
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Blood-based correlative studies: genetic polymorphisms (EGFR, DNA repair, inflammatory gene pathways) and serologic analysis (EGFR, VEGF, bFGF, pro-MMP2 levels)
Time Frame: 8-10 years
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8-10 years
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Recurrence rates and failure patterns following the treatment regimen.
Time Frame: 5-7 years
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5-7 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Korst, MD, Valley Health Systems/ The Valley Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Neoplasms by Site
- Thoracic Neoplasms
- Neoplasms, Complex and Mixed
- Thymoma
- Thymus Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Etoposide
- Cisplatin
Other Study ID Numbers
- VHS07.0006a
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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