The purpose of this study is to determine the feasibility of treatment in patients with high risk endometrial cancer treated by vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy.
Before the patient begins the study: Endometrial cancer is commonly treated with surgery. The patient must have already had surgery including hysterectomy (removal of the uterus) prior to being considered eligible for this study. The surgery may also include removal of pelvic and para-aortic lymph nodes. Following the surgery, the doctor will identify if the patient has factors related to the cancer which places the patient at a greater risk for the cancer returning. Prior to participating in this study there are exams, tests or procedures to find out if the patient can be treated in the study. Most are part of regular cancer care. Treatment: All patients will receive radiation therapy followed by three cycles of dose dense paclitaxel and carboplatin chemotherapy. Radiation therapy will be delivered either by LDR or HDR brachytherapy and must be specified at the time of enrollment. The vaginal brachytherapy should be started within 12 weeks of surgery (within 2 weeks of enrollment). Chemotherapy should start within 3 weeks of initiating brachytherapy. Study participation will be up to two years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted
Carboplatin IV on day 1 of a 21 day cycle for 3 cycles
Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Number of Patients Completing the Protocol
Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy
Time frame: 4 months
Frequency of Adverse Events Related to Acute Toxicity During Treatment
Frequency and severity of adverse events as assessed by the CTCAE v4
Time frame: 4 months
Sites of Failure
Proportion of participants who experienced failure in regional or distant sites
Time frame: up to 2 years
Recurrence-free Survival
time from study entry to the first tumor recurrence
Time frame: up to 2 years
Contributing Cause of Death
The contributing cause of death for patients with high risk endometrial cancer
Time frame: up to 2 years
Overall Survival
time from study entry to death
Time frame: up to 2 years
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