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

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Mar 16, 2018

Keywords

ClinConnect Summary

The PORTEC-4a trial is studying the best ways to treat women with early-stage endometrial cancer that has certain high-risk features. Specifically, the trial is comparing a new method of deciding on treatment based on a detailed analysis of the cancer’s characteristics (called a molecular profile) to the standard treatment, which is vaginal brachytherapy. Depending on their individual risk profiles, participants might receive no additional therapy, vaginal brachytherapy, or another type of radiation called external beam radiotherapy.

To participate in this trial, women need to have a specific type of endometrial cancer (called endometrioid type) at stage I or II, along with certain other factors like age or tumor characteristics. Eligible participants will also need to be in good overall health and provide written consent to join. If involved, they can expect to be randomly assigned to one of the treatment options and will be monitored throughout the process. This trial is currently active but not recruiting new participants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• * Histologically confirmed endometrioid type endometrial carcinoma, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I, with one of the following combinations of stage, grade, age, and lymph-vascular space invasion (LVSI):
• • 1. Stage IA, grade 3 (any age, with or without LVSI)
• • 2. Stage IB, grade 1 or 2 and age \>60 years
• • 3. Stage IB, grade 1-2 with documented LVSI
• • 4. Stage IB, grade 3 without LVSI
• • 5. Stage II (microscopic), grade 1
• • World Health Organization (WHO)-performance status 0-2
• • Written informed consent
• Exclusion Criteria:
• • Any other stage and type of endometrial carcinoma
• • Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma
• • Uterine sarcoma (including carcinosarcoma)
• • Previous malignancy (except for non-melanomatous skin cancer) \< 5 yrs
• • Previous pelvic radiotherapy
• • Expected interval between the operation and start of radiotherapy exceeding 8 weeks