Uterine Papillary Serous Cancer (UPSC) Trial
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|ClinicalTrials.gov Identifier: NCT00147680|
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : February 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Uterine Cancer||Drug: Paclitaxel, Carboplatin||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Non-randomised Phase 2 Clinical Trial of Carboplatin Plus Paclitaxel With Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||October 2009|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147680
|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|