PORTEC-4: Randomised Phase III Trial Comparing Vaginal Brachytherapy (two doses schedules: 21 or 15 Gy HDR in 3 fractions) and Observation after Surgery in patients with Endometrial Carcinoma with High-Intermediate Risk Features

Phase 3

Recruiting

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

• Registration Number: NL-OMON39610
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

To be eligible for this trial, patients will need to meet all of the following inclusion criteria:
1. Histologically confirmed endometrioid type endometrial carcinoma, FIGO stage I, with one of the following combinations of substage, age, and grade:
a. Stage IA, any age, grade 3 without lymph-vascular space invasion (LVSI)
b. Stage IB, age 60 years or older and grade 1 or 2
c. Stage IB, any age, grade 1 or 2 with documented lymph-vascular space invasion (LVSI)
2. Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral Salpingo-Oophorectomy (TH-BSO). Although pelvic lymphadenectomy is not recommended; if this has been done the patient is still eligible.
3. WHO-performance status 0-2
4. Written informed consent

Exclusion Criteria

The following criteria exclude the patient from enrolment in this trial:
1. Any other stage of endometrial carcinoma
2. Non-endometrioid endometrial carcinoma, such as serous or clear cell carcinoma
3. Uterine sarcoma (including carcinosarcoma)
4. Previous malignancy (except for non-melanomatous skin cancer) < 5 yrs
5. Previous pelvic radiotherapy
6. 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 objectives:<br /><br>Establish vaginal recurrence and 5-year vaginal control including treatment for<br /><br>relapse in patients with high-intermediate risk endometrial carcinoma, treated<br /><br>after surgery with vaginal brachytherapy (21 Gy or 15 Gy in 3 fractions), in<br /><br>comparison with no additional treatment<br /><br><br /><br>Primary endpoint: vaginal recurrence<br /><br>Second primary endpoint: 5-year vaginal control including treatment for relapse</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives:<br /><br>Establish and compare the rates of vaginal toxicity, quality of life, pelvic<br /><br>recurrence, and overall and failure-free survival.<br /><br>Secondary endpoints:<br /><br>Overall and failure-free survival;<br /><br>Pelvic recurrence;<br /><br>Vaginal adverse effects;<br /><br>General and specific quality of life (including sexual functioning and<br /><br>symptoms, if applicable). </p><br>