Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer (GOG 249)
To determine if vaginal cuff brachytherapy and chemotherapy (VCB/C) increases recurrence-free survival compared with pelvic radiation therapy (RT) in high-risk early-stage endometrial carcinoma
Type of study
Randomised controlled trial (RCT)
Radiation therapy vs Vaginal cuff brachytherapy and chemotherapy
Experimental arm (Intervention)
Vaginal cuff brachytherapy followed by IV paclitaxel 175mg/m2 (3 hours) plus carboplatin every 21 days for three cycles
Radiation therapy (45 to 50.4 Gy over 5 weeks)
Recurrence free survival
- Overall survival
- Pelvic or para-aortic nodal recurrences
- Acute and late toxicity
- Stage I endometrial cancer of endmetrioid adenocarcinoma histology meeting the following criteria:
- Age 70 years or older with one uterine risk factor
- Age 50 years or older with two risk factors
- Age 18 years or older with three risk factor
- Uterine risk factors included:
- Grade 2 or 3 tumor
- Outer half depth of invasion
- Lymphovascular invasion
- Positive or negative peritoneal cytology were allowed (endometroid)
- Patients with serous or clear cell tumors with stage I or II with negative peritoneal cytology
- Wrong stage
- Wrong cell type
- Wrong primary
- Inadequate pathological materials
- Risk criteria not met
- No tumor at entry
Vaginal and distal recurrence rates were similar between arms.
Acute toxicity was more frequent and severe in the vaginal cuff brachytherapy with chemotherapy arm.
Late toxicity was similar.
Pelvic radiotherapy remains the standard of care. It is effective, well-tolerated, and appropriate adjuvant treatment in high-risk early-stage endometrial carcinoma of all histologies.