Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients

Status:Active, not recruiting
Conditions:Cervical Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Age Range:18 - Any
Start Date:February 2006
End Date:July 2016

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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

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.

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 this protocol, but not
those with distant metastases

Exclusion Criteria:

- Age < 18

- Karnofsky Performance Status < 60

- Radiographic or pathologic evidence of distant metastatic disease

- Prior pelvic radiation therapy, other than trans-vaginal ring brachytherapy
irradiation for acute hemostasis
We found this trial at
St. Louis, Missouri 63108
St. Louis, MO
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