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IMRT Tomotherapy for Esophagus Cancer: A Phase I Feasibility Study in Non-Operative Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Esophagus Cancer

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Trial Information

IMRT Tomotherapy for Esophagus Cancer: A Phase I Feasibility Study in Non-Operative Patients


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in patients with unresectable esophagus cancer.

Outcome Description:

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

Outcome Time Frame:

One year after protocol registration

Safety Issue:

Yes

Principal Investigator

Jeffrey Bradley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

06-1070 / 201105499

NCT ID:

NCT00593723

Start Date:

December 2006

Completion Date:

November 2016

Related Keywords:

  • Esophagus Cancer
  • IMRT
  • Esophageal Neoplasms

Name

Location
Washington University School of Medicine Saint Louis, Missouri  63110