Preoperative Treatment of Patients With High Risk Thymoma

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Valley Health System
• Treatments: Cisplatin; Etoposide; Etoposide phosphate

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.