Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation

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.

Timeline

Start

2020-05-20

Primary completion

2022-08-30

Completion

2023-01-30

Outcome

Outcome not reported

Stopped (Enrollment): “could not enroll anyone due to staff changes”

Publications

• Background Sherman ME, Devesa SS. Analysis of racial differences in incidence, survival, and mortality for malignant tumors of the uterine corpus. Cancer. 2003 Jul 1;98(1):176-86. doi: 10.1002/cncr.11484.
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• Results Moore KN, Fader AN. Uterine papillary serous carcinoma. Clin Obstet Gynecol. 2011 Jun;54(2):278-91. doi: 10.1097/GRF.0b013e318218c755.

Drugs

Indications