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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Thymoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

16 weeks

Safety Issue:

No

Principal Investigator

Robert Korst, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Valley Health Systems/ The Valley Hospital

Authority:

United States: Institutional Review Board

Study ID:

VHS07.0006a

NCT ID:

NCT00387868

Start Date:

October 2006

Completion Date:

October 2021

Related Keywords:

  • Thymoma
  • Thymoma
  • Thymic carcinoma
  • Preoperative chemotherapy and radiation
  • Response rate
  • Thymoma

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617
Methodist HospitalHouston, Texas  77030
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Valley Health System - The Valley HospitalRidgewood, New Jersey  07450