View Clinical Trial (Medical Research Study)
Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients
| City: |
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St. Louis |
| State: |
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Missouri |
| Zip Code: |
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63110 |
| Conditions: |
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Uterine Cervical Neoplasms |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- Age > 18
- Karnofsky Performance Status of > 60
- FIGO Stage I -IIB
- Pathologic confirmation of cervical cancer
- Status post hysterectomy
- Patients with local or regional metastases are eligible for htis protocol, but not
those with distant metastases
Exclusion Criteria:
- Age < 18
- Karnofsky Performance Status < 60
- Radiographic or pathologic evidence of metastatic disease (other than pelvic or
para-aortic lymph nodes)
- Prior pelvic radiation therapy, other than trans-vaginal ring brachytherapy
irradiation for acute hemostasis
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| NCT ID: |
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NCT00359866 |
| Primary Contact: |
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Principal Investigator
Perry W Grigsby, M.D.
Washington University Medical School
Regina Smith, AA
Phone: 314-454-7986
Email: smithr1@wudosis.wustl.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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St. Louis, Missouri 63110
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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