A randomized phase III trial of cisplatin and tumor volume directed irradiation followed by carboplatin and paclitaxel vs. Carboplatin and paclitaxel for optimally debulked, advanced endometrial carcinoma
Principal Investigator
Daniela Matei, MD
Status
Closed to Accrual
Date Opened To Accrual
June 29 2009
Date Closed to Accrual
July 28 2014
Disease Site
Gynecologic [GY]
Uterine Corpus
Phase
III
Developmental Therapeutics
No
Primary Objective
To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with Stages III-IVA endometrial carcinoma (<2 cm residual disease) or patients with FIGO 2009 Stage I or II serous (UPSC) or clear cell endometrial carcinoma and positive cytology.
Patient Population
Patients with Stages III-IVA endometrial carcinoma (<2 cm residual disease) or patients with FIGO 2009 Stage I or II serous (UPSC) or clear cell endometrial carcinoma and positive cytology.
Target Accrual
804
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.