Phase II Study of Trimodality Therapy for Patients With Thymoma or Thymic Carcinoma at Significant Risk for Recurrence
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
16 weeks
No
Robert Korst, MD
Principal Investigator
Valley Health Systems/ The Valley Hospital
United States: Institutional Review Board
VHS07.0006a
NCT00387868
October 2006
October 2021
Name | Location |
---|---|
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Methodist Hospital | Houston, Texas 77030 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Valley Health System - The Valley Hospital | Ridgewood, New Jersey 07450 |