Researchers are seeking to interrogate 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 compared with standard adjuvant vaginal brachytherapy.
Patients enrolled into the experimental arm of the trial will receive internal radiation of the vaginal vault using a vaginal cylinder (21 Gy in 3 outpatient sessions over 2 weeks), external beam pelvic radiotherapy on a linear accelerator (48.6 Gy in 27 outpatient sessions over 5.5 weeks), or observation.
Eligible patients are 18 years and older with histologically confirmed endometrioid type endometrial carcinoma of International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I and a World Health Organization (WHO)-performance status of 0 to 2.
Participants are not eligible for the trial if they have any other stage and type of endometrial carcinoma, have histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or have undifferentiated or neuroendocrine carcinoma. Participants with uterine sarcoma (including carcinosarcoma), previous malignancy (except for nonmelanomatous skin cancer) in the last 5 years, previous pelvic radiotherapy, or who have an a interval between the operation and start of radiotherapy exceeding 8 weeks cannot enroll in the trial.
To review the full list of exclusion and inclusion criteria please refer to the reference.
Title: Trial to Evaluate PORTEC-4a: Molecular Profile-Based vs Standard Adjuvant Radiotherapy in Endometrial Cancer
Remi Nout, MD, PhD of the ErasmusMC Dept of Radiation Oncology
Description: Patients are randomly assigned to a standard
arm of VBT or an experimental arm consisting of observation, VBT, or EBRT, depending on the molecular risk profile.
Status: The study is ongoing and recruiting patients as of March 19, 2018.
This study is sponsored by Leiden University Medical Center.
Clinicaltrials.gov. PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer (PORTEC-4a). NCT03469674. https://clinicaltrials.gov/ct2/show/NCT03469674. Accessed on October 26, 2020.