Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients
Patients with cervical cancer receiving post-operative radiotherapy (RT) for high risk
features found on pathologic review will be treated with pelvic intensity modulated
radiation therapy (IMRT). Helical tomotherapy will be used to plan and deliver the
radiation treatment. Treatment volume will include the upper third of the vagina and
para-vaginal tissue and the common, external and internal iliac nodal regions. External
beam radiation will be delivered in 180 cGy daily fractions to a total dose of 5040 cGy.
Patients will receive once a day treatment five days a week, for approximately 6 weeks.
Concurrent chemotherapy and/or intracavitary brachytherapy may be included in the treatment
plan at the discretion of the treating physician, consistent with routine clinical practice.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the feasibility of using helical tomotherapy to deliver IMRT
Feasibility is defined as the ability to deliver 95% of the prescription dose to 90% of the original planning target volume in at least 90% of the patients, as verified by actual dose delivered calculations using on board CT scan.
After all patients are enrolled and complete treatment
Perry W Grigsby, M.D.
Washington University Medical School
United States: Institutional Review Board
05-0977 / 201104019
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