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Preoperative Treatment of Patients With High Risk Thymoma

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ClinicalTrials.gov Identifier: NCT00387868
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):
Valley Health System

Tracking Information
First Submitted Date  ICMJE October 11, 2006
First Posted Date  ICMJE October 13, 2006
Last Update Posted Date December 9, 2014
Study Start Date  ICMJE October 2006
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 11, 2006)
Complete pathological response
Change History Complete list of historical versions of study NCT00387868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2014)
  • Radiographic response to preoperative chemoradiotherapy by comparing pre and post treatment CT scans. [ Time Frame: 16 weeks ]
  • Rate of complete resection following preoperative chemoradiotherapy as determined by pathologic examination of the specimen(s). [ Time Frame: 1-5 weeks ]
  • Toxicities throughout the study treatment. [ Time Frame: 5 years ]
  • 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 ]
  • Immunohistochemical assessment of relevant markers before and after chemoradiation (EGFR, p53,and Ki-67). [ Time Frame: 10-12 years ]
  • 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 ]
  • Recurrence rates and failure patterns following the treatment regimen. [ Time Frame: 5-7 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2006)
  • Radiographic response to preoperative chemoradiotherapy by comparing pre and post treatment CT scans.
  • Rate of complete resection following preoperative chemoradiotherapy as determined by pathologic examination of the specimen(s).
  • Toxicities throughout the study.
  • 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
  • Immunohistochemical assessment of relevant markers before and after chemoradiation (EGFR, p53, MHC Class I, CD80, CD86, CD95).
  • Blood-based correlative studies: genetic polymorphisms (EGFR, DNA repair, inflammatory gene pathways) and serologic analysis (EGFR, VEGF, bFGF, pro-MMP2 levels)
  • Recurrence rates and failure patterns following the treatment regimen.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Treatment of Patients With High Risk Thymoma
Official Title  ICMJE Phase II Study of Trimodality Therapy for Patients With Thymoma or Thymic Carcinoma at Significant Risk for Recurrence
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thymoma
Intervention  ICMJE
  • 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
  • Procedure: Surgical Resection
    Resection will take place 4-8 weeks after completion of radiotherapy.
  • Radiation: Concurrent Radiotherapy
    Preoperative External Beam Radiotherapy
Study Arms  ICMJE
  • Registration
    Cisplatin, Etoposide & concurrent radiotherapy
    Interventions:
    • Drug: cisplatin and etoposide
    • Radiation: Concurrent Radiotherapy
  • Surgical Resection
    No distant Progression post Registration Arm
    Intervention: Procedure: Surgical Resection
  • Post Resection
    Assessment post surgical procedure to determine if at higher risk of recurrence or if complete resection could not be achieved.
    Intervention: Drug: cisplatin and etoposide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2014)
21
Original Enrollment  ICMJE
 (submitted: October 11, 2006)
30
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00387868
Other Study ID Numbers  ICMJE VHS07.0006a
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Valley Health System
Study Sponsor  ICMJE Valley Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Korst, MD Valley Health Systems/ The Valley Hospital
PRS Account Valley Health System
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP