Status:
COMPLETED
Preoperative Treatment of Patients With High Risk Thymoma
Lead Sponsor:
Valley Health System
Conditions:
Thymoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
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 rem...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00387868
Start Date
October 1 2006
End Date
November 1 2014
Last Update
December 9 2014
Active Locations (2)
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1
Valley Health System - The Valley Hospital
Ridgewood, New Jersey, United States, 07450
2
University of Toronto
Toronto, Ontario, Canada, M5G2C4