Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00359866|
Recruitment Status : Completed
First Posted : August 3, 2006
Last Update Posted : June 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Uterine Cervical Neoplasms||Radiation: IMRT with tomotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||January 2016|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|