PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Vaginal brachytherapy: Internal radiation of the vaginal vault using a vaginal cylinder, 21 Gy in 3 out-patient sessions over 2 weeks

External beam radiotherapy: External beam pelvic radiotherapy on a linear accelerator, 48.6 Gy in 27 out-patients sessions over 5.5 weeks

Observation: No radiation therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment

Study summary

This is prospective, multicenter, randomised phase III trial among women with endometrial cancer with high-intermediate risk features to investigate the role of an integrated clinicopathological and molecular risk profile to determine if participants should receive no adjuvant therapy, vaginal brachytherapy or external beam radiotherapy based on a favourable, intermediate or unfavourable profile as compared to standard adjuvant vaginal brachytherapy.

Eligibility

Primary outcome measure(s)

• Vaginal recurrence — 5 years
  Total vaginal recurrence and vaginal recurrence as first failure

Trial sites (31)

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