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NCT Number: NCT03469674

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

This is prospective, multicenter, randomised phase III trial among women with endometrial cancer with high-intermediate risk features to investigate 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 based on a favourable, intermediate or unfavourable profile as compared to standard adjuvant vaginal brachytherapy.

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Key information

Conditions

Endometrial Cancer Stage I Endometrial Cancer Stage II Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Medical University, Vienna, Vienna, Austria

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About this study

Adjuvant therapy for women with endometrial cancer has increasingly been tailored to prognostic factors to prevent overtreatment and select those women for adjuvant treatment who will have a clinically relevant reduction of the risk of relapse by the adjuvant treatment. Risk profiles have traditionally been based on clinicopathological factors such as age, stage, grade, LVSI and depth of invasion. Newer, both molecular-genetic (the cancer genome atlas subgroups) or immunohistochemistry-based (L1-CAM) risk factors have become available which are strongly related to outcomes and risk of cancer spread. In a comprehensive analysis of the PORTEC-1 and-2 biobank an integrated clinicopathological and molecular risk profile was determined which separated the current high-intermediate risk group of endometrial cancer in 3 separate groups (favourable, intermediate or unfavourable) with clearly separated outcomes, which is now prospectively tested in the clinic to determine adjuvant treatment. This is the first randomised trial using the molecular risk factors to assign adjuvant treatment for women with stage I-II high-intermediate risk endometrial cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • Stage IA, grade 3 (any age, with or without LVSI)
  • Stage IB, grade 1 or 2 and age >60 years
  • Stage IB, grade 1-2 with documented LVSI
  • Stage IB, grade 3 without LVSI
  • 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

Treatment and study plan

Vaginal brachytherapy

Radiation

Internal radiation of the vaginal vault using a vaginal cylinder, 21 Gy in 3 out-patient sessions over 2 weeks

External Beam Radiotherapy

Radiation

External beam pelvic radiotherapy on a linear accelerator, 48.6 Gy in 27 out-patients sessions over 5.5 weeks

observation

Other

No radiation therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment

Primary outcomes

  1. Vaginal recurrence

    Time frame: 5 years

    Total vaginal recurrence and vaginal recurrence as first failure

Secondary outcomes

  1. Adverse events

    Time frame: 5 years

    Treatment-related symptoms according to CTCAE v 4.0

  2. Health-related cancer-specific quality of life

    Time frame: 5 years

    Cancer-specific quality of life (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQC-30) - clinically relevant changes on QLQC30 functioning scales, general quality of life and general cancer symptoms

  3. Endometrial cancer-related symptoms and quality of life

    Time frame: 5 years

    Endometrial cancer-related specific symptoms (EORTC EN24 module)- clinically relevant changes on these scales (quite a bit/very much vs no or mild symptoms)

  4. Relapse-free survival

    Time frame: 5 years

    Relapse-free survival (survival without relapse)

  5. Survival

    Time frame: 5 years

    Overall survival (all-cause death)

  6. 5-year vaginal control including treatment for relapse

    Time frame: 5 years

    Long-term local control including salvage treatment for local relapse

  7. Pelvic recurrence (total)

    Time frame: 5 years

    Total pelvic recurrences

  8. Pelvic recurrence as first failure

    Time frame: 5 years

    Pelvic recurrence as first failure

  9. Distant recurrence (total)

    Time frame: 5 years

    Total distant recurrences

  10. Distant recurrence as first failure

    Time frame: 5 years

    Distant recurrence as first failure

  11. Endometrial cancer related health care costs

    Time frame: 5 years

    All hospital based health care costs used with primary treatment or during followup for treatment of adverse events and/or treatment for relapse

Other outcomes

  1. Recurrence (vaginal and total) per risk profile

    Time frame: 5 years

    Vaginal, pelvic and distant relapse split by risk profile and compared between the 2 arms

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Comprehensive Cancer Centre The Netherlands
  • Dutch Cancer Society

Registry information

Official study title

Randomised Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Radiotherapy for Women With Early Stage Endometrial Cancer: PORTEC-4a Trial

Acronym: PORTEC-4a

Important dates

Study start
2016
Primary completion
2024
Study completion
2028
First posted
Mar 19, 2018
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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