Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation
Status:
Not yet recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
Uterine serous carcinoma (USC) is an uncommon, but aggressive variant of endometrial
carcinoma that has poor response to standard therapy. After staging and surgery, radiation
therapy and/or chemotherapy is recommended to treat patients at high risk for recurrence. In
advanced stage and recurrent setting, high risk uterine cancer mirrors ovarian cancer with it
spread patterns and response to therapy. Based on these findings and the similarities as well
as the clinical success of paclitaxel with IP platinum therapy in patients with ovarian
serous carcinoma, investigators propose to prospectively assess IV/IP therapy in patients
with advanced stage and recurrent USC.
During Week 1-18, subjects will be placed on open-label IP Carboplatin/IV Paclitaxel on Day
1, then administered IP Paclitaxel on Day 8. This will be repeated every 3 weeks for 6
cycles. A CT imaging scan will be performed after six cycles of chemotherapy, prior to
radiation. Also, in Week 19-23, subjects will receive Pelvic radiation therapy (IMRT) if
deemed necessary. Additionally, from Week 24-26, High Dose Radiation or IMRT will be used
where appropriate.
Patients will be monitored for toxicity and feasibility of the regimen. Secondary outcomes
will include assessing the frequency and the reasons for early discontinuation of the study
treatments as well as describing patient-reported quality of life parameters at specified
time points during the study using validated questionnaires: EORTC QLQ-C30 and QLQ-OV28.