Clinical trial NCT00359866: Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients
Official title: Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Cervical Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Uterine Cervical Neoplasms
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2006-08-03
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the feasibility of using helical tomotherapy to deliver IMRT
timeFrame: After all patients are enrolled and complete treatment
Secondary outcomes:
measure: Measure the acute toxicity
timeFrame: Up through 30 days after completion of treatment
measure: Measure the late toxicity
timeFrame: Starting 30 days from completion of treatment through 1 year post start of treatment
measure: Measure the local, regional, and distant recurrence rates
timeFrame: 5 years after completion of treatment
measure: Measure the 5-year disease free and 5-year overall survival rates
timeFrame: 5 years after completion of treatment
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University Medical School
name: Perry W Grigsby, M.D.
role: PRINCIPAL_INVESTIGATOR
References: