Prospective, Non-randomised Phase 2 Clinical Trial of Carboplatin Plus Paclitaxel With Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer
- 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.
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:
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety and efficacy of the combination of paclitaxel and carboplatin plus/minus (+/-) pelvic radiotherapy in the treatment of UPSC
Australia: Department of Health and Ageing Therapeutic Goods Administration
UPSC - 001