Uterine Papillary Serous Cancer (UPSC) Trial
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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 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
|Study Start Date:||September 2004|
|Study Completion Date:||October 2009|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
- 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.
|QCGC, Royal Brisbane and Women's Hospital|
|Herston, Queensland, Australia, 4029|
|Mater Adult Public Hospital|
|South Brisbane, Queensland, Australia, 4101|
|Principal Investigator:||Andreas Obermair||QCGC|