NCT00147680

Uterine Papillary Serous Cancer (UPSC) Trial

Prospective, Non-randomised Phase 2 Clinical Trial of Carboplatin Plus Paclitaxel With Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Queensland Centre for Gynaecological Cancer · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Uterine Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel, Carboplatin

Timeline

• Start date: 2004-09-01
• Primary completion: 2008-06-01
• Completion: 2009-10-01
• First posted: 2005-09-07
• Last updated: 2012-02-02

Locations

2 sites across 1 country: Australia