IMRT Tomotherapy for Esophagus Cancer - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00593723

Purpose

The hypothesis of this study is that the use of IMRT instead of conventional 4-field irradiation in patients with locally-advanced esophagus cancer receiving adjuvant RT is a feasible treatment alternative. IMRT may reduce the rate of pulmonary, cardiac, and bowel toxicity while allowing an intensified dose of radiation therapy to be delivered to the cancer.

Condition	Intervention
Esophagus Cancer	Radiation: Tomotherapy

MedlinePlus related topics: Cancer Esophageal Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	IMRT Tomotherapy for Esophagus Cancer: A Phase I Feasibility Study in Non-Operative Patients

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: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate local, regional and distant recurrence rates Evaluate disease-free and overall survival rates [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2016
Estimated Primary Completion Date:	November 2016 (Final data collection date for primary outcome measure)

Intervention Details:

The radiation treatment is standard of care. The machine (Tomotherapy) on which the treatment is delivered offers standard treatment in a new way

Detailed Description:

In this study, we will give you radiation therapy through a system called tomotherapy. Tomotherapy is designed to target the tumor and regions at risk more precisely than conventional radiation therapy. Tomotherapy involves delivering the radiation doses in a corkscrew or helical fashion, attacking the tumor from 360 degrees, rather than from only 3 or 4 directions.

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, N0-1, M0-M1a
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
Contact: Linda M. Brockman 314-454-7986 brockmal@ccadmin.wustl.edu
Principal Investigator: Jeffrey Bradley, MD

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Jeffrey Bradley, MD

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Washington University School Of Medicine ( Jeffrey Bradley, MD )
Study ID Numbers:	06-1070
Study First Received:	January 2, 2008
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00593723 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Esophageal Disorder
Gastrointestinal Diseases
Head and Neck Neoplasms

Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Cancer
Esophageal Diseases

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009