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Search / Trial NCT00387868

Preoperative Treatment of Patients With High Risk Thymoma

Launched by VALLEY HEALTH SYSTEM · Oct 11, 2006

Trial Information

Current as of June 06, 2025

Completed

Keywords

Thymoma Thymic Carcinoma Preoperative Chemotherapy And Radiation Response Rate

ClinConnect Summary

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 resectabilit...

Gender

ALL

Eligibility criteria

  • 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.

About Valley Health System

Valley Health System is a comprehensive healthcare provider dedicated to delivering high-quality patient care and advancing medical research through innovative clinical trials. With a robust network of hospitals, outpatient facilities, and specialized programs, Valley Health System emphasizes a patient-centered approach, ensuring that participants in clinical trials receive exceptional support and access to cutting-edge therapies. Committed to advancing medical knowledge and improving health outcomes, the organization collaborates with leading researchers and institutions to conduct rigorous trials across various therapeutic areas, fostering a culture of excellence in clinical research and patient safety.

Locations

Ridgewood, New Jersey, United States

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Robert Korst, MD

Principal Investigator

Valley Health Systems/ The Valley Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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