Brief Title
Selective Targeting of Adjuvant Therapy for Endometrial Cancer (STATEC)
Official Title
A Randomised Trial of Non-selective Versus Selective Adjuvant Therapy in High Risk Apparent Stage 1 Endometrial Cancer
Brief Summary
The primary aim of this trial is to determine whether lymphadenectomy, used to restrict
adjuvant therapy (other than vaginal brachytherapy) to node positive women, results in a
non-inferior survival as compared to adjuvant therapy given to all women with high risk
apparent stage 1 endometrial cancer.
Detailed Description
Results from this trial have the potential to change practice whatever the results: either
lymphadenectomy will become recommended practice if a non-inferior outcome is obtained;
otherwise the procedure can be safely abandoned.
Secondary Objectives
- Disease-free, endometrial cancer-event free and endometrial cancer-specific survival
- Distribution of pelvic and extra-pelvic relapse
- Cost effectiveness
- Surgical adverse events
There are also two sub-studies:
1. Quality of life - all patients i. Describe the trajectory of key patient reported
outcomes (PROs) from baseline up to 5 years post-surgery ii. Compare the specific PRO
domains between the trial arms at several specific time points iii. Determine the
proportion of women in each trial arm reporting long-term symptoms after treatment as
measured by the symptom-specific subscales of the measures (gastrointestinal symptoms,
urological symptoms, attitude to disease and treatment, vaginal symptoms, lymphoedema)
iv. Determine the correlation between physician rating (CTCAE v4.03) and patient-report
(corresponding PRO subscale) for various symptoms reported by both physicians and
patients v. Assess the correlation between self-assessed lymphoedema (Self-report
lower-extremity lymphoedema screening questionnaire) and the lymphoedema subscale of the
Quality of Life Questionnaire-Endometrial Cancer Module (QLQ-EN24)
We hypothesise that quality of life will be better in patients in the lymphadenectomy
arm because a considerable proportion will be spared systemic adjuvant treatment, from
which they may not benefit.
2. Sentinel lymph node (SLN) - optional for Arm 1 patients
The aim of this sub-study is to assess SLN status in comparison with the overall lymph node
status after full lymph node dissection (LND), and so determine whether SLN is as accurate as
systematic node dissection.
i. We aim to determine the diagnostic performance of the SLN procedure compared to the gold
standard of LND ii. To evaluate whether SLN status is a prognostic marker of survival iii. To
model patient relapse and survival based on low volume micro-metastatic (LVM) and individual
tumour cell (ITC) status
Study Type
Interventional
Primary Outcome
Overall survival
Secondary Outcome
Disease-free survival
Condition
Endometrial Cancer
Intervention
Abdominal surgery
Study Arms / Comparison Groups
Abdominal surgery with lymphadenectomy
Description: Patients will receive a hysterectomy and bilateral salpingo-oophorectomy (BSO)* with lymph node dissection to determine whether lymph nodes are positive or negative: Positive: patients will receive systemic adjuvant treatment to include chemotherapy Negative: patients will receive vaginal brachytherapy only Patients will then be followed up, to include assessment of adverse events and quality of life. *There is an option for patients to be randomised following a pre-trial hysterectomy and BSO. If randomised to this arm, the lymph node dissection will be performed as a separate procedure.
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
Procedure
Estimated Enrollment
49
Start Date
April 12, 2017
Completion Date
August 14, 2019
Primary Completion Date
August 14, 2019
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed high risk apparent International Federation of Gynecology and
Obstetrics (FIGO) stage I endometrial cancer according to one of the following
criteria. Confirmation must be based on either diagnostic endometrial sampling or
hysterectomy and BSO specimen if randomisation occurring after hysterectomy and BSO:
1. FIGO grade 3 endometrioid or mucinous carcinoma
2. High grade serous, clear cell, undifferentiated or dedifferentiated carcinoma or
mixed cell adenocarcinoma or carcinosarcoma
- Surgery to be performed ≤ 5 weeks after randomisation in patients randomised prior to
hysterectomy and BSO. Patients randomised after hysterectomy and BSO must have
undergone hysterectomy and BSO ≤ 28 days prior to randomisation. Patients randomised
after hysterectomy and BSO who are allocated lymphadenectomy must undergo
lymphadenectomy ≤ 5 weeks after randomisation
- Written informed consent
- No prior anticancer therapy for endometrial cancer
- Eastern Cooperative Oncology Group (EGOC) performance status 0-2
- Life expectancy > 3 months
- Age ≥ 16 years
- Adequate organ and bone marrow function
- Ability to undergo post-operative chemotherapy with or without radiotherapy
- Adjuvant treatment to commence ≤ 8 weeks after surgery
- Willingness and ability to complete Quality of Life questionnaires
Exclusion Criteria:
- Grossly enlarged node(s) of ≥ 10 mm short axis on baseline radiological imaging
- Invasion of the cervical stroma on baseline radiological imaging or obvious cervical
disease on clinical examination
- Involvement of uterine serosa or metastatic disease seen outside the uterus on
baseline radiological imaging
- Small cell carcinoma with neuroendocrine differentiation
- Concurrent anti-cancer therapy
- Previous malignancy < 5 years prior to randomisation or concurrent malignant disease
with the exception of:
1. carcinoma in situ of cervix
2. non-melanoma skin cancer
3. basal cell carcinoma
4. melanoma in situ
- Women who are pregnant or lactating
Gender
Female
Ages
16 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Tim Mould, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT02566811
Organization ID
UCL/13/0630
Responsible Party
Sponsor
Study Sponsor
University College, London
Study Sponsor
Tim Mould, Principal Investigator, University College London Hospital
Verification Date
June 2019