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IMRT Tomotherapy for Esophagus Cancer

This study is currently recruiting participants.
Verified March 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00593723
First received: January 2, 2008
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

Concurrent chemotherapy and radiation therapy are the standard of care for inoperable patients with esophagus cancer. Unfortunately, the 5-year survival of 20% for this population is quite low. Methods to intensify radiation therapy delivery without increasing local toxicities are needed. Intensity modulated radiation therapy (IMRT) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. The proposed study will prospectively test whether IMRT is tolerable for delivering IMRT doses of 60 Gy for patients with esophagus cancer.


Condition Intervention
Esophagus Cancer
 Radiation: IMRT
Drug: Concurrent chemotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IMRT Tomotherapy for Esophagus Cancer: A Phase I Feasibility Study in Non-Operative Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in patients with unresectable esophagus cancer. [ Time Frame: One year after protocol registration ] [ Designated as safety issue: Yes ]

    The study will be deemed infeasible if one or more of the following results occur:

    • 15% of patients experience any grade 4 acute toxicity judged to be related to his/her external radiation treatment

      • within 1 year of protocol registration, >15% of patients develop any grade 4 late toxicity judged to be related to his/her external radiation treatment
      • within 1 year of protocol registration, any patient dies from causes judged to be related to his/her external beam radiation treatment


Secondary Outcome Measures:
  • Evaluate local, regional and distant recurrence rates [ Time Frame: Until patient progressive disease or death ] [ Designated as safety issue: No ]
    6 weeks after therapy, every 3 months for first two years post therapy, every 6 months for years 3, 4, and 5 post therapy, and then annually.

  • Evaluate disease-free and overall survival rates [ Time Frame: Until patient progressive disease or death ] [ Designated as safety issue: No ]
    6 weeks after therapy, every 3 months for first two years post therapy, every 6 months for years 3, 4, and 5 post therapy, and then annually.


Estimated Enrollment: 40
Study Start Date: December 2006
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT + Concurrent chemotherapy

180 cGy daily fractions to a total dose of 5400 cGy to PTV1 and 200 cGy daily fractions to a total dose of 6000 cGy to PTV2. Once a day, five days a week, for approximately 6 weeks.

Planned chemotherapy: cisplatin (75 mg/m2) day 1 and 5-FU (1000 mg/m2) days 1-4 on weeks 1, 5, 10, and 14 of therapy. Please note that drug regimens and doses may vary and will be at the discretion of the medical oncologist.

 Radiation: IMRT Drug: Concurrent chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18
  • Karnofsky Performance Status of >= 60
  • TNM Stages T1-4, N0-3, M0
  • Pathologic confirmation of esophagus cancer
  • Evaluation by medical oncologist determines that the patient is medically fit for concurrent chemotherapy
  • Evaluation by surgeon determines that patient is unresectable

Exclusion Criteria:

  • Age < 18
  • Karnofsky Performance Status < 60
  • Radiographic or pathologic evidence of distant metastatic disease (classified as M1b in AJCC staging manual)
  • Prior radiation therapy to the thorax or upper abdomen, preventing definitive radiation therapy.
  • Pregnant or lactating, if female.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593723

Contacts
Contact: Jeffrey Bradley, MD (314) 362-8525 bradley@radonc.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Jeffrey Bradley, MD            
Sub-Investigator: Murty Goddu, Ph.D.            
Sub-Investigator: Sasa Mutic, M.S.            
Sub-Investigator: A Craig Lockhart, M.D.            
Sub-Investigator: Feng Gao, M.D., Ph.D.            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jeffrey Bradley, MD Washington University School of Medicine
  More Information

Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00593723     History of Changes
Other Study ID Numbers: 06-1070 / 201105499
Study First Received: January 2, 2008
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
IMRT

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 22, 2013