Endometrial CancerSTATECNCT02566811
Selective Targeting of Adjuvant Therapy for Endometrial Cancer (STATEC)
A study testing Abdominal surgery and Lymphadenectomy in people with Endometrial Cancer, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Abdominal surgery and Lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Apr 2017to 14 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- FIGO grade 3 endometrioid or mucinous carcinoma
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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:
Show all 11Show fewer
- carcinoma in situ of cervix
- non-melanoma skin cancer
- basal cell carcinoma
- melanoma in situ
- Women who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College Hospital
London, Greater London
About this study
Official title: A Randomised Trial of Non-selective Versus Selective Adjuvant Therapy in High Risk Apparent Stage 1 Endometrial Cancer
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.
Read the 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:
- 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.
- 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.
- 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
- Conditions
- Endometrial Cancer
- Being tested
- Abdominal surgery, Lymphadenectomy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal surgeryProcedure or surgery
Hysterectomy defined as an extrafascial hysterectomy whereby the cervix is removed completely but no radical dissection of the parametria is required
LymphadenectomyProcedure or surgery
Bilateral pelvic and para-aortic lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Abdominal surgery with lymphadenectomy | Experimental | 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. Receives: Procedure: Abdominal surgery; Procedure: Lymphadenectomy |
| Abdominal surgery, no lymphadenectomy | Active comparator | Patients will receive a hysterectomy and bilateral salpingo-oophorectomy (BSO)*. Patients will receive systemic adjuvant treatment to include chemotherapy.
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, no further surgery will be given and the patient will proceed to receive systemic adjuvant treatment to include chemotherapy. Receives: Procedure: Abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: 5 years
Secondary outcomes (6)
Disease-free survival
Disease-free survival
Measured: 5 years
Endometrial cancer-event free survival
Endometrial cancer-event free survival
Measured: 5 years
Endometrial cancer-specific survival
Endometrial cancer-specific survival
Measured: 5 years
Pelvic and extra-pelvic relapse-free survival
Measured: 5 years
Cost effectiveness
Cost effectiveness
Measured: 5 years
Surgical adverse events
Surgical adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start12 Apr 2017
- Primary completion14 Aug 2019
- Study completion14 Aug 2019
Why it stopped: Withdrawal of funding by CR UK due to poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Mould, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566811
- Sponsor's protocol ID
- UCL/13/0630
- Acronym
- STATEC
- Status last verified
- Jun 2019
- First submitted
- 22 Sep 2015
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of Non-selective Versus Selective Adjuvant Therapy in High Risk Apparent Stage 1 Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02566811
- Acronym / sponsor ID
- STATEC / UCL/13/0630
- Conditions
- Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawal of funding by CR UK due to poor recruitment
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 14 Aug 2019 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal surgery with lymphadenectomy | Experimental | Procedure: Abdominal surgery, Procedure: LymphadenectomyPatients 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. |
| Abdominal surgery, no lymphadenectomy | Active comparator | Procedure: Abdominal surgeryPatients will receive a hysterectomy and bilateral salpingo-oophorectomy (BSO)*. Patients will receive systemic adjuvant treatment to include chemotherapy. 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, no further surgery will be given and the patient will proceed to receive systemic adjuvant treatment to include chemotherapy. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal surgeryHysterectomy defined as an extrafascial hysterectomy whereby the cervix is removed completely but no radical dissection of the parametria is required | Procedure or surgery | Abdominal surgery with lymphadenectomy, Abdominal surgery, no lymphadenectomy |
| LymphadenectomyBilateral pelvic and para-aortic lymph node dissection | Procedure or surgery | Abdominal surgery with lymphadenectomy |
Primary outcome
Overall survival
Time frame: 5 years
Overall survival
6 secondary outcomes
Disease-free survival
Time frame: 5 years
Endometrial cancer-event free survival
Time frame: 5 years
Endometrial cancer-specific survival
Time frame: 5 years
Pelvic and extra-pelvic relapse-free survival
Time frame: 5 years
Cost effectiveness
Time frame: 5 years
Surgical adverse events
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Withdrawal of funding by CR UK due to poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Mould principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal surgery and Lymphadenectomy in people with Endometrial Cancer, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Withdrawal of funding by CR UK due to poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.