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

NCT00359866CompletedPHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Washington University School of Medicine

Enrollment

28

Start Date

2006-02-01

Completion Date

2010-07-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

IMRT with tomotherapy

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Determine the feasibility of using helical tomotherapy to deliver IMRT

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.

Time frame: After all patients are enrolled and complete treatment

Secondary Outcomes

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

Locations

Washington University School of Medicine, St Louis, United States