Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147680
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2005-09-06
Brief Title:
Uterine Papillary Serous Cancer UPSC Trial
Sponsor:
Queensland Centre for Gynaecological Cancer
Organization:
Queensland Centre for Gynaecological Cancer
Study Overview
Official Title:
Prospective Non-randomised Phase 2 Clinical Trial of Carboplatin Plus Paclitaxel With Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 paclitaxelcarboplatin followed by whole pelvic external beam radiotherapy to a standard pelvis field 504 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 surgeons and the medical oncologists 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 125 - 25 mg IV
Cimetidine 300 mg or ranitidine 50 mg IV
Dexamethasone 20 mg IV
Paclitaxel 175 mgm2
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 504 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
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 surgeons and the medical oncologists 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 125 - 25 mg IV
Cimetidine 300 mg or ranitidine 50 mg IV
Dexamethasone 20 mg IV
Paclitaxel 175 mgm2
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 504 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None