Preoperative Treatment of Patients With High Risk Thymoma



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/1/2014
Start Date:October 2006
End Date:October 2021
Contact:Susan Mock, RN
Email:smock@valleyhealth.com
Phone:201-634-5792

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Phase II Study of Trimodality Therapy for Patients With Thymoma or Thymic Carcinoma at Significant Risk for Recurrence

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.

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.

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.
We found this trial at
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Ridgewood, New Jersey 07450
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Houston, TX
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