Preoperative Treatment of Patients With High Risk Thymoma

NCT ID: NCT00387868

Last Updated: 2014-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2014-11-30

Brief 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.

Detailed Description

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.

Conditions

Thymoma

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Registration

Cisplatin, Etoposide \& concurrent radiotherapy

Group Type: OTHER

cisplatin and etoposide

Intervention Type: DRUG

Cisplatin: 50mg/m2 - administered on days 1,8,29\&36 Etoposide: 50 mg/m2 - administered on days 1-5 \& 29-33

Concurrent Radiotherapy

Intervention Type: RADIATION

Preoperative External Beam Radiotherapy

Surgical Resection

No distant Progression post Registration Arm

Group Type: OTHER

Surgical Resection

Intervention Type: PROCEDURE

Resection will take place 4-8 weeks after completion of radiotherapy.

Post Resection

Assessment post surgical procedure to determine if at higher risk of recurrence or if complete resection could not be achieved.

Group Type: OTHER

cisplatin and etoposide

Intervention Type: DRUG

Cisplatin: 50mg/m2 - administered on days 1,8,29\&36 Etoposide: 50 mg/m2 - administered on days 1-5 \& 29-33

Interventions

cisplatin and etoposide

Cisplatin: 50mg/m2 - administered on days 1,8,29\&36 Etoposide: 50 mg/m2 - administered on days 1-5 \& 29-33

Intervention Type: DRUG

Surgical Resection

Resection will take place 4-8 weeks after completion of radiotherapy.

Intervention Type: PROCEDURE

Concurrent Radiotherapy

Preoperative External Beam Radiotherapy

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valley Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Korst, MD

Role: PRINCIPAL_INVESTIGATOR

Valley Health Systems/ The Valley Hospital

Locations

Valley Health System - The Valley Hospital

Ridgewood, New Jersey, United States

University of Toronto

Toronto, Ontario, Canada

Countries

United States; Canada

References

Korst RJ, Bezjak A, Blackmon S, Choi N, Fidias P, Liu G, Marx A, Wright C, Mock S, Rutledge JR, Keshavjee S. Neoadjuvant chemoradiotherapy for locally advanced thymic tumors: a phase II, multi-institutional clinical trial. J Thorac Cardiovasc Surg. 2014 Jan;147(1):36-44, 46.e1. doi: 10.1016/j.jtcvs.2013.08.061. Epub 2013 Oct 15.

Reference Type: DERIVED

PMID: 24139613 (View on PubMed)

Wright CD, Choi NC, Wain JC, Mathisen DJ, Lynch TJ, Fidias P. Induction chemoradiotherapy followed by resection for locally advanced Masaoka stage III and IVA thymic tumors. Ann Thorac Surg. 2008 Feb;85(2):385-9. doi: 10.1016/j.athoracsur.2007.08.051.

Reference Type: DERIVED

PMID: 18222230 (View on PubMed)

Other Identifiers

VHS07.0006a

Identifier Type: -

Identifier Source: org_study_id

NCT00509522

Identifier Type: -

Identifier Source: nct_alias