Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy With Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma: PORTEC-3
- Compare the overall survival and failure-free survival of patients with high-risk stage
IB-III endometrial carcinoma treated with concurrent chemoradiotherapy followed by
adjuvant chemotherapy vs pelvic radiotherapy alone.
- Compare the rates of pelvic and distant recurrence, severe (grades 3 and 4)
treatment-related toxicity, and quality of life of patients treated with these
This is a multicenter, prospective, open-label, randomized, controlled study. Patients are
stratified according to participating group (DGOG vs UK NCRI vs NCIC CTG vs MaNGO vs
Unicancer), type of surgery (total abdominal hysterectomy and bilateral
salpingo-oophorectomy [TAH-BSO] vs TAH-BSO plus lymphadenectomy vs laparoscopic hysterectomy
[TLH-BSO] vs TLH-BSO plus lymphadenectomy), stage (IA vs IB vs II vs III), and histological
type (endometrioid carcinoma vs serous or clear cell carcinoma). Patients are randomized to
1 of 2 treatment arms.
- Arm I: Patients receive external-beam pelvic radiotherapy 5 days a week for up to 6
weeks, combined with cisplatin IV days 1 and 22. Patients with cervical involvement
undergo vaginal brachytherapy boost. At least 3 weeks after completion of
chemoradiotherapy, patients undergo adjuvant chemotherapy comprising paclitaxel IV and
carboplatin IV on day 1. Adjuvant chemotherapy repeats every 3 weeks for up to 4
courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients undergo external-beam pelvic radiotherapy (and vaginal brachytherapy
alone in case of cervical involvement) as in arm I.
Quality of life is assessed at baseline, completion of radiotherapy, completion of
chemotherapy, at 6 months, and then once a year for 5 years.
After completion of study therapy, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Carien L. Creutzberg, MD, PhD
Leiden University Medical Center
Netherlands: Medical Ethics Review Committee (METC)