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Therapeutic Areas: Oncology | Otolaryngology (Ear, Nose, Throat)
Disease Category: Thymomas
Location: United States, NJ
Clinical Trial Details
Research Study Summary
Preoperative Treatment of Patients With High Risk Thymoma
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.
Ages Eligible for Study:
Genders Eligible for Study:
- Biopsy-proven thymoma or thymic carcinoma.
- Invasive thymoma determined by specific radiographic criteria
determined by CT scan.
- Acceptable kidney, liver, bone marrow, and respiratory
- 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
Patient 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.
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
Key Secondary Outcomes:
- Radiographic response to preoperative chemoradiotherapy by
comparing pre and post treatment CT scans.
- Rate of complete resection following preoperative
chemoradiotherapy as determined by pathologic examination of the
- Toxicities throughout the study.
- 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
- Immunohistochemical assessment of relevant markers before and
after chemoradiation (EGFR, p53,and Ki-67).
- Blood-based correlative studies: genetic polymorphisms (EGFR,
DNA repair, inflammatory gene pathways) and serologic analysis
(EGFR, VEGF, bFGF, pro-MMP2 levels)
- Recurrence rates and failure patterns following the treatment
To Learn more
Both Male and Female
Date Last Changed:
July 25, 2013
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