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Therapeutic Areas: Oncology | Otolaryngology (Ear, Nose, Throat)
Disease Category: Thymomas
Location: United States, NJ

Clinical Trial Details

Overview

Research Study Summary

Preoperative Treatment of Patients With High Risk Thymoma

Purpose

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:

  • 18 Years - 80 Years

Genders Eligible for Study:

  • Both

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

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.

Primary Outcomes:
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.

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 specimen(s).
  • 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 scans
  • 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 regimen.
To Learn more
Gender

Both Male and Female

Age

18 to 80 Years

Overall Status

Recruiting

Facility Type

N/A

Contact

Susan Mock, BSN, Study Coordinator
The Valley Hospital/Valley Health System
1 Valley Health Plaza
Paramus, NJ 07450
Phone: 201-634-5793
Fax: 201-634-5383

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Research Center Information: The Valley Hospital/Valley Health System

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 120690

Date Last Changed: July 25, 2013


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