This study will be an open, non-randomised, clinical phase 2 trial, which will involve 30 women diagnosed with uterine papillary serous cancer. The researchers will investigate the effect of four cycles of paclitaxel/carboplatin, followed by whole pelvic external beam radiotherapy to a standard pelvis field (50.4 Gy) with or without a para-aortic boost with respect to the safety and efficacy of treatment, and patterns of recurrence.
Trial Objectives: * To assess the safety and efficacy of the combination of Paclitaxel and Carboplatin +/- pelvic radiotherapy in the treatment of UPSC. * To observe the patterns of recurrence following the administration of the combination of Paclitaxel and Carboplatin +/- pelvic radiotherapy in the treatment of UPSC. * To assess the QOL, overall survival and disease free survival. Treatment Surgery: Total abdominal hysterectomy, bilateral salpingo-oophorectomy, +/- pelvic and aortic node sampling, omentectomy, peritoneal cytology. Chemotherapy: Chemotherapy commences at the surgeon's and the medical oncologist's discretion and the time between surgery and start of chemotherapy will be recorded. One treatment cycle consists of 3 weeks. Paclitaxel and Carboplatin will be administered as follows: Day 1: * Diphenhydramine 50 mg IV or po or phenergan 12.5 - 25 mg IV * Cimetidine 300 mg or ranitidine 50 mg IV * Dexamethasone 20 mg IV * Paclitaxel 175 mg/m2 * Carboplatin AUC 6 Day 22: Repeat the cycle. This is Day 1 of the second cycle. Day 43: Repeat the cycle. This is Day 1 of the third cycle. Day 64: Repeat the cycle. This is Day 1 of the fourth cycle. Day 85: After the fourth cycle of chemotherapy patients Patients with stage 4 disease will continue with chemotherapy for a total of 6 cycles. Patients with surgical stage 1b to 3c disease will receive whole pelvis external beam radiotherapy (50.4 Gy RD over 5 and a half weeks +/- paraaortic boost +/- vaginal vault brachytherapy boost). Radiotherapy will start 4 to 6 weeks after commencement of chemotherapy when the haematological count has recovered.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
QCGC, Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Mater Adult Public Hospital
South Brisbane, Queensland, Australia
To assess the safety and efficacy of the combination of paclitaxel and carboplatin plus/minus (+/-) pelvic radiotherapy in the treatment of UPSC
To observe the patterns of recurrence following the administration of the combination of paclitaxel and carboplatin +/- pelvic radiotherapy in the treatment of UPSC
To assess the quality of life (QOL), overall survival and disease free survival
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