Brief Title
PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer
Official 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
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Vaginal recurrence
Secondary Outcome
Adverse events
Condition
Endometrial Cancer Stage I
Intervention
Vaginal brachytherapy
Study Arms / Comparison Groups
Molecular profile based treatment
Description: Determination of the integrated clinicopathological and molecular profile to determine adjuvant treatment: observation for favourable profile; vaginal brachytherapy for intermediate profile; external beam radiotherapy for unfavourable profile
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
500
Start Date
June 10, 2016
Completion Date
December 2028
Primary Completion Date
December 2026
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
- Interval between the operation and start of radiotherapy exceeding 8 weeks
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Carien L. Creutzberg, MD, PhD, +3165263057, c.l[email protected]
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT03469674
Organization ID
P16.054
Secondary IDs
UL2011-5336
Responsible Party
Principal Investigator
Study Sponsor
Leiden University Medical Center
Collaborators
Dutch Cancer Society
Study Sponsor
Carien L. Creutzberg, MD, PhD, Study Chair, Leiden University Medical Center, Dept of Radiation Oncology
Verification Date
February 2020