Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.
The study will be deemed infeasible if greater than 10% of patients experience one of the following: Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her. The patient experiences any grade 4 acute toxicity judged to be related to her external radiation treatment. Within 1 year of the start of radiation therapy, the patient develops any grade 4 late toxicity judged to be related to her external radiation treatment. Within 1 year of the start of radiation therapy, the patient develops any in-field pelvic recurrence. Within 1 year of the start of radiation therapy, the patient dies from causes judged to be related to her treatment.
1 year from the start of radiation therapy.
Perry W Grigsby, M.D.
Washington University School of Medicine
United States: Institutional Review Board
06-0297 / 201106410
|Washington University School of Medicine||Saint Louis, Missouri 63110|