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Trial registered on ANZCTR


Registration number
ACTRN12617000714381
Ethics application status
Approved
Date submitted
8/05/2017
Date registered
17/05/2017
Date last updated
10/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of nonselective versus selective adjuvant therapy in high risk apparent stage 1 endometrial cancer.
Scientific title
A randomised trial of nonselective versus selective adjuvant therapy in high risk apparent stage 1 endometrial cancer.
Secondary ID [1] 291877 0
ClinicalTrials.gov NCT02566811
Secondary ID [2] 291880 0
University College London: UCL/13/0630
Secondary ID [3] 291881 0
Cancer Research UK: CRUK/14/043
Secondary ID [4] 291884 0
ANZGOG: ANZGOG1311/2016
Secondary ID [5] 291885 0
NHMRC Clinical Trials Centre: CTC 0129
Universal Trial Number (UTN)
Trial acronym
STATEC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endometrial cancer 303173 0
Condition category
Condition code
Cancer 302613 302613 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
STATEC is testing the use of a surgical procedure called lymphadenectomy (or lymph gland removal) to help guide further treatment in women with endometrial (womb) cancer. In patients who undergo lymph gland removal, the results of the lymph gland removal (e.g. node negative or node positive) will be used to select further (adjuvant) treatment.
Patients will be randomised to one of the following two arms, either prior to surgery or following hysterectomy and bilateral salpingo-oophorectomy (BSO):
Group 1: Randomised treatment will be hysterectomy and BSO, plus lymphadenectomy. Patients randomised prior to hysterectomy and BSO will receive the lymphadenectomy as part of the same operation as the hysterectomy and BSO. Patients randomised after hysterectomy and BSO will receive the lymphadenectomy as a separate operation. Adjuvant treatment will then be determined by lymph node status. Node positive patients will receive adjuvant treatment to include chemotherapy with or without external radiotherapy, while node negative patients will receive brachytherapy (internal radiotherapy) only.
Group 2: Randomised treatment will be a hysterectomy and BSO without lymphadenectomy. Patients randomised after hysterectomy and BSO will receive no further surgery. Patients will then receive adjuvant treatment to include chemotherapy with or without external radiotherapy.
The chemotherapy, external radiotherapy and/or brachytherapy for patients in both Group 1 and Group 2 will be given as per standard practice at the treating hospital.
Intervention code [1] 297997 0
Treatment: Surgery
Comparator / control treatment
The comparator treatment is surgery (hysterectomy and BSO) with NO lymph glands removed. After the surgery, all of the women in this group will receive chemotherapy with or without radiation therapy as per standard practice at the treating institution.
Control group
Active

Outcomes
Primary outcome [1] 302029 0
Overall survival (measured from the date of randomisation until the date of death from any cause)
Timepoint [1] 302029 0
Until death from any cause
Secondary outcome [1] 334543 0
Disease-free survival (measured from the date of randomisation until date of first recurrence, a new secondary tumour or death from any cause, whichever occurs first)
Timepoint [1] 334543 0
Until date of first recurrence or death
Secondary outcome [2] 334544 0
Endometrial cancer-event free survival (measured from the date of randomisation until recurrence or death from endometrial cancer, or treatment related deaths, whichever occurs first)
Timepoint [2] 334544 0
Until recurrence or death from endometrial cancer
Secondary outcome [3] 334546 0
Endometrial cancer-specific survival (measured from the date of randomisation until death from endometrial cancer, or treatment-related deaths)
Timepoint [3] 334546 0
Until death from endometrial cancer or treatment
Secondary outcome [4] 334547 0
Pelvic and extra-pelvic relapse-free survival (composite outcome as assessed by radiological imaging at time of relapse with documentation of site/s of relapse)
Timepoint [4] 334547 0
Until relapse
Secondary outcome [5] 334548 0
Cost effectiveness (using the EQ-5D-5L for economic evaluation)
Timepoint [5] 334548 0
Time frame: 5 years after surgery
Secondary outcome [6] 334549 0
Surgical adverse events (acute and late) as assessed by the Common Terminology Criteria for Adverse Events v4.03
Timepoint [6] 334549 0
Time frame: 3 months after surgery

Eligibility
Key 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:
a.FIGO grade 3 endometrioid or mucinous carcinoma
b.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
Minimum age
16 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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:
a.carcinoma in situ of cervix
b.non-melanoma skin cancer
c.basal cell carcinoma
d.melanoma in situ

* Women who are pregnant or lactating

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur centrally by computer. Patients will be randomised in a 1:1 ratio according to the following stratification factors:
a. participating site
b. histology:
c. lymphovascular space invasion
d. timing of hysterectomy and BSO
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis
The study plans to enrol 2000 participants internationally (including 240 in Australia/New Zealand).
The overall non-inferiority margin of 5 percentage points was agreed by the investigators to be clinically acceptable to patients and surgeons.
Using the exponential parameter of 0.0040, allowable hazard ratio of 1.272, and assuming 48 months accrual then a further 48 months study follow up (i.e. a maximum length of follow up of 96 months), requires 2000 patients to be recruited (500 deaths), with 85% power, and 5% two-sided statistical significance. With 80% power, the sample size is 1720 patients (430 deaths), and this would be the minimum target.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8886 0
United Kingdom
State/province [1] 8886 0
Country [2] 8887 0
New Zealand
State/province [2] 8887 0
Country [3] 8888 0
Netherlands
State/province [3] 8888 0

Funding & Sponsors
Funding source category [1] 296378 0
Government body
Name [1] 296378 0
National Health and Medical Research Council
Address [1] 296378 0
GPO Box 1421
Canberra ACT 2601
Country [1] 296378 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown
NSW, 2006
Country
Australia
Secondary sponsor category [1] 295327 0
None
Name [1] 295327 0
Address [1] 295327 0
Country [1] 295327 0
Other collaborator category [1] 279562 0
University
Name [1] 279562 0
University College London
Address [1] 279562 0
90 Tottenham Court Road
London
W1T 4TJ

Country [1] 279562 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297616 0
RPAH Zone of the Sydney Local Health District
Ethics committee address [1] 297616 0
Research Ethics and Governance Office
Suite 210A
RPA Medical Centre
Cnr Missenden Road and Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 297616 0
Australia
Date submitted for ethics approval [1] 297616 0
16/01/2017
Approval date [1] 297616 0
07/06/2017
Ethics approval number [1] 297616 0
X17-0001 & HREC/17/RPAH/1

Summary
Brief summary
This study is testing the use of a surgical procedure called lymphadenectomy (or lymph gland removal) to help guide further treatment in women with endometrial (womb) cancer.

Who is it for?
You may be eligible to join this study if you are a woman aged 16 years or above, have histologically confirmed high risk apparent International Federation of Gynecology and Obstetrics (FIGO) stage I endometrial cancer.

Study details
Patients will be randomly allocated to one of two groups, Group 1 or Group 2.

Patients in Group 1 will have surgery with lymph glands removed. The results of the lymph glands will be used to decide on the further treatment. Women with cancer in their lymph nodes (‘node positive’) will receive chemotherapy with or without radiotherapy. Women with no cancer in their lymph nodes (‘node negative’) will only receive an internal form of radiotherapy called brachytherapy and will not be given chemotherapy or external radiotherapy.

Patients in Group 2 will have surgery with no lymph glands removed. After surgery, all women in this group will then receive chemotherapy with or without external radiotherapy.

Specifics of the chemotherapy and radiotherapy will vary depending on the specific institution and individual doctor conducting the study.

The purpose of this study is to find out whether there is any difference in clinical response between patients in Group 1 and those in Group 2 and to determine whether lymph gland removal improves quality of life in some patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74598 0
A/Prof Alison Brand
Address 74598 0
c/o STATEC Study Team
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown, NSW
1450
Country 74598 0
Australia
Phone 74598 0
+61 2 9562 5000
Fax 74598 0
Email 74598 0
Alison.Brand@health.nsw.gov.au
Contact person for public queries
Name 74599 0
Ms STATEC Trial Coordinator
Address 74599 0
c/o STATEC Study Team
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown, NSW
1450
Country 74599 0
Australia
Phone 74599 0
+61 2 9562 5000
Fax 74599 0
Email 74599 0
statec@ctc.usyd.edu.au
Contact person for scientific queries
Name 74600 0
A/Prof Alison Brand
Address 74600 0
c/o STATEC Study Team
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown, NSW
1450
Country 74600 0
Australia
Phone 74600 0
+61 2 9562 5000
Fax 74600 0
Email 74600 0
Alison.Brand@health.nsw.gov.au

No data has been provided for results reporting
Summary results
Not applicable