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Preoperative Treatment of Patients With High Risk Thymoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00387868
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : December 9, 2014
Information provided by (Responsible Party):
Valley Health System

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.

Condition or disease Intervention/treatment Phase
Thymoma Drug: cisplatin and etoposide Procedure: Surgical Resection Radiation: Concurrent Radiotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Trimodality Therapy for Patients With Thymoma or Thymic Carcinoma at Significant Risk for Recurrence
Study Start Date : October 2006
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer
Drug Information available for: Etoposide

Arm Intervention/treatment
Cisplatin, Etoposide & concurrent radiotherapy
Drug: cisplatin and etoposide
Cisplatin: 50mg/m2 - administered on days 1,8,29&36 Etoposide: 50 mg/m2 - administered on days 1-5 & 29-33

Radiation: Concurrent Radiotherapy
Preoperative External Beam Radiotherapy

Surgical Resection
No distant Progression post Registration Arm
Procedure: Surgical Resection
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.
Drug: cisplatin and etoposide
Cisplatin: 50mg/m2 - administered on days 1,8,29&36 Etoposide: 50 mg/m2 - administered on days 1-5 & 29-33

Primary Outcome Measures :
  1. 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 [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Radiographic response to preoperative chemoradiotherapy by comparing pre and post treatment CT scans. [ Time Frame: 16 weeks ]
  2. Rate of complete resection following preoperative chemoradiotherapy as determined by pathologic examination of the specimen(s). [ Time Frame: 1-5 weeks ]
  3. Toxicities throughout the study treatment. [ Time Frame: 5 years ]
  4. 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 [ Time Frame: 10 years ]
  5. Immunohistochemical assessment of relevant markers before and after chemoradiation (EGFR, p53,and Ki-67). [ Time Frame: 10-12 years ]
  6. Blood-based correlative studies: genetic polymorphisms (EGFR, DNA repair, inflammatory gene pathways) and serologic analysis (EGFR, VEGF, bFGF, pro-MMP2 levels) [ Time Frame: 8-10 years ]
  7. Recurrence rates and failure patterns following the treatment regimen. [ Time Frame: 5-7 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00387868

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United States, New Jersey
Valley Health System - The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5G2C4
Sponsors and Collaborators
Valley Health System
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Principal Investigator: Robert Korst, MD Valley Health Systems/ The Valley Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Valley Health System Identifier: NCT00387868    
Obsolete Identifiers: NCT00509522
Other Study ID Numbers: VHS07.0006a
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014
Keywords provided by Valley Health System:
Thymic carcinoma
Preoperative chemotherapy and radiation
Response rate
Additional relevant MeSH terms:
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Thymus Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action