Randomised Phase Ill Trial of molecular profile-based versus standard recommendations for adjuvant radiotherapy for women with early stage endometrial cancer: PORTEC-4a

Phase 3

Recruiting

• Conditions: Endometrial cancer; cancer of the womb; 10038594

• Registration Number: NL-OMON54837
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 450

Inclusion Criteria

Adult patients with histologically confirmed endometrioid type endometrial
carcinoma, FIGO 2009 stage I, with one of the following combinations of stage,
grade, age, and 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
Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral
Salpingo-Oophorectomy (TH-BSO) with or without pelvic lymphadenectomy, lymph
node sampling or sentinel node procedure (not recommended, but permitted)
WHO-performance status 0-2
Written informed consent

Exclusion Criteria

The following criteria exclude the patient from enrolment in this trial:
1. Any other stage and type of endometrial. carcinoma
2. Non-endometrioid endometrial carcinoma, such as serous or clear cell
carcinoma (at least 10% in mixed types), or undifferentiated or neuroendocrine
carcinoma
3. Uterine sarcoma (including carcinosarcoma)
4. Previous malignancy (except for non-melanomatous skin cancer) < 5 yrs
5. Previous pelvic radiotherapy
6. Verwacht interval between the operation and start of radiotherapy exceeding
8 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: vaginal recurrence</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>Adverse events and patient-reported symptoms and health-related quality of life<br /><br>Recurrence-free and overall survival<br /><br>Pelvic and distant recurrence<br /><br>5-year vaginal control (including treatment for relapse if applicable)<br /><br>Endometrial cancer - related healthcare costs</p><br>