Trial name or title | 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 |
Methods | Randomisation to either volume-directed radiotherapy with complex platinum based chemotherpay or 6 cycles conventional dose Carboplatin plus Paclitaxel. Additionally, tissue is stored for translational research |
Participants | All women have surgical stage III or IVA endometrial carcinoma per FIGO 1988 staging criteria of any histological type. Surgical Stage III disease includes tumour invading the serosa, tumour in the adnexa, pelvic and/or para-aortic nodes, or vaginal involvement. Women with tumour cells in the pelvic washings as the only extra-uterine disease are eligible only if the histology is clear cell or serous papillary. Surgical Stage IVA includes patients with bladder or bowel mucosal involvement, but no spread outside the pelvis. Interim analysis in January 2011 shows that initial data was available from 61 women and all had stage 3 disease Partisipants have a GOG Performance Status of 0, 1, or 2 and are 18 years of age or older. Entry into the study is limited to no more than 8 weeks from the date of surgery. Surgery involves a hysterectomy and bilateral salpingo-oophorectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional The volume of residual disease after surgery must be less than 2cm in any dimension |
Interventions | Participants are randomly allocated to either
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Outcomes | 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) |
Starting date | The study opened to recruitment on June 29, 2009 |
Contact information | The study chairs for the GOG include Daniela Matei, Marcus E. Randall, David Mutch, Ursula A. Matulonis, Michael J. Birrer and Margaret Steinhoff. I-Chow Hsu represents the RTOG |
Notes | The target recruitment is 804. By July 2010, 69 women had been recruited |