Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients
Indications for post-hysterectomy radiation therapy (RT) have been well established by clinical data. Adjuvant RT has demonstrated local control and survival benefit. In patients with nodal disease, adjuvant chemotherapy concurrent with radiation has further improved the clinical outcome. The acute hematological and gastrointestinal toxicity of concurrent chemo-radiotherapy can be quite high, sometimes preventing patients from completed their full treatment course, potentially compromising the therapeutic benefit of treatment. Intensity modulated radiation therapy (IMRT) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. Helical tomotherapy is a novel treatment device with sophisticated imaging and treatment delivery features that are optimally suited for IMRT. There are retrospective clinical data supporting the use of non-tomotherapy delivered IMRT to treat patients with gynecologic cancers. The proposed study will prospectively test whether helical tomotherapy is a feasible method for delivering IMRT in post-hysterectomy cervical cancer patients receiving adjuvant RT. Here, the question of feasibility is simply one of verifying that target volumes are reliably covered by 'sculpted' IMRT high-dose regions. Although this is not a treatment effectiveness study, we will also follow the clinical outcome of these patients, including toxicity, local control and survival, in anticipation that this information will be valuable if the treatment modality is judged feasible and will be used for further treatments of this patient population.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients|
- The primary goal of the study is to determine the feasibility of delivering dosimetrically adequate therapy, while limiting toxic high dose regions using helical tomotherapy intensity modulation. [ Time Frame: Patients will be followed for disease status and for the appearance of late toxicity every 3 month for the first 2 years, 6 months for 2-5 year post therapy, annually for after 5th year post therapy ] [ Designated as safety issue: Yes ]
- A secondary objective is to determine the optimum planning target volume margins in this patient population, as a basis for future practice. [ Time Frame: Patients will be followed for disease status and for the appearance of late toxicity every 3 month for the first 2 years, 6 months for 2-5 year post therapy, annually for after 5th year post therapy ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2006|
|Estimated Study Completion Date:||February 2030|
|Estimated Primary Completion Date:||February 2030 (Final data collection date for primary outcome measure)|
Helical tomotherapy will be used to plan and deliver the radiation treatment.
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.
|Contact: Regina Smith, AAemail@example.com|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Perry W Grigsby, M.D.||Washington University Medical School|