Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients|
- Determine the feasibility of using helical tomotherapy to deliver IMRT [ Time Frame: After all patients are enrolled and complete treatment ]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.
- Measure the acute toxicity [ Time Frame: Up through 30 days after completion of treatment ]
- Measure the late toxicity [ Time Frame: Starting 30 days from completion of treatment through 1 year post start of treatment ]
- Measure the local, regional, and distant recurrence rates [ Time Frame: 5 years after completion of treatment ]
- Measure the 5-year disease free and 5-year overall survival rates [ Time Frame: 5 years after completion of treatment ]
|Study Start Date:||February 2006|
|Study Completion Date:||January 2016|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: Pelvic IMRT with Tomotherapy
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 160-180 cGy daily fractions to a total dose of 4500-5120 cGY.
Receive treatment once a day for five days a week for approximately 6 weeks.
Treating physician will make determination if patient is to receive intracavitary brachytherapy.
Treating physician will make determination if patient is to receive chemotherapy (allowed but not mandated).
|Radiation: IMRT with tomotherapy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359866
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Perry W Grigsby, M.D.||Washington University Medical School|