PORTEC-4: Randomised trial investigating the role and optimal dose of vaginal brachytherapy for endometrial cancer.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29071

Enrollment

500

Registered

2012-01-29

Start date

2012-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial carcinoma Keywords: Radiotherapy, vaginal brachytherapy, randomised trial, adjuvant treatment, endometrial cancer, risk factors

Interventions

Patients are randomised (2:1) to receive vaginal brachytherapy (standard arm), or observation after surgery (experimental arm)

patients in the vaginal brachytherapy group are randomized 1:1 to standard dose (21 Gy in 3 Gy fractions), or reduced dose (15 Gy in 3 fractions).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed endometrioid type endometrial carcinoma, FIGO 2009 stage I, with one of the following combinations of substage, age, and grade: A. Stage IA, age 60 years or older and grade 3; B. Stage IB, age 60 years or older and grade 1 or 2; C. Stage IB, any age, grade 1-2 with documented lymph-vascular space invasion (LVSI). 2. Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral Salpingo-oophorectomy (TH-BSO); 3. WHO-performance status 0-2; 4. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Any other stage and type of endometrial carcinoma; 2. Histological types papillary serous carcinoma 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.

Design outcomes

Primary

Measure	Time frame
Primary endpoint: Vaginal recurrence; Second primary endpoint: 5-year vaginal control including treatment for relapse.	—

Secondary

Measure	Time frame
1. Vaginal toxicity; 2. Quality of life; 3. Pelvic recurrence; 4. Overall survival.	—

Contacts

Public ContactC.L. Creutzberg

Leiden University Medical Center (LUMC), Department of Clinical Oncology, P.O. Box 9600

c.l.creutzberg@lumc.nl+31 (0)71 5263027

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)