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G0258 A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel versus Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma
Protocol Number:
Phase III
Deborah Armstrong
- 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 ( less than 2 cm residual disease)or patients with FIGO 2009 Stage I or II serous (UPSC) or clear cell endometrial carcinoma and positive cytology. - To compare the regimens with respect to acute and late adverse effects of therapy - To determine the impact on patient-reported Quality of Life during and following treatment for up to 1 year with the two treatment regimens
- stage II or IVA endometrial cancer including clear cell and serous papillary and undifferentiated carcinomas - Stage I or II endometrial clear cell of serous - good performance status and lab values - must have hysterectomy - no prior chemotherapy for endometrial cancer
Treatment: Randomized 1:1 Regimen I equal to Cisplatin IV on Days 1 and 29 plus volume-directed radiation followed by Taxol/Carboplatin IV every 21 days for 4 cycles Regimen II equal to Taxol/Carboplatin IV every 21 days for 6 cycles
Last Update
07/31/2014 04:02 AM

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