To determine the clinical effectiveness of adjuvant therapy given to all unstaged (no lymph node dissection) high risk stage 1 endometrial cancer, compared with only node positive (staged) cases as judged by fulllymph node dissection.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall survival
Secondary outcome
Progressien-free survival
Distribution of pelvic and extra-pelvic relapse
Surgical side effects
Cost effectiveness
Two side studies will be conducted aimed at:
1) Quality of life
2) The diagnostic performance of sentinel lymph node procedure compared to
lymphadenectomy
Background summary
Endometrial cancer is the most camman gynaecological cancer in the Netherlands.
Primary surgical treatment consists of hysterectomy and bilateral
salpingo-oophorectomy (BSO). Controversy exists over the use of lymph node
staging and the effectiveness of adjuvant treatment in patients with a high
risk of recurrence. Without lymph node dissection, clinicopathological
prognostic factors are used to select adjuvant treatment and all wamen with
high risk of recurrent disease will be affered further treatment. This study
will demonstrata the optimal surgical treatment and use of adjuvant therapy
for wamen with high risk stage 1 endometrial cancer, rasuiting in eliminatien
of the wide variatien in practica across developed countries.
Study objective
To determine the clinical effectiveness of adjuvant therapy given to all
unstaged (no lymph node dissection) high risk stage 1 endometrial cancer,
compared with only node positive (staged) cases as judged by fulllymph node
dissection.
Study design
Randomised, non-inferiority multicentre trial. Patients will be recruited in
the United Kingdom, Australia, New Zealand and the
Netherlands. Patients will be randomised over two study-groups.
Intervention
Subjects will be randomised to have hysterectomy with BSO plus either staging
with a systematic pelvic and para-aartic lymph node dissection, or na node
dissection. All wamen in the unstaged arm will receive adjuvant therapy due to
the risk of node invalvament and/or relapse of 15-20%. In the staged arm, only
wamen with positive nodes wilI receive adjuvant therapy.
Study burden and risks
The STATEC trial will address the ongoing international debate regarding
lymphadenectomy for the treatment of high risk endometrial cancer. The two
strategies to be investigated in this trial reprasent the two most widely
accepted, and most frequently performed treatment options. Consequently,
patients in this trial will not face any new risks compared to standard
treatment. All fellow-up procedures will be performed during regular fellow-up
appointments. Patients with negative nodes will not receive
chemotherapyfradiation and therefore will not face the well known side effects
associated with this standard adjuvant treatment. When deamed necessary these
patients will receive adjuvant treatment with vaginal brachytherapy to reduce
the risk on a recurrence as much as possible. Frequent check-ups wilI ensure
rapid dateetion and intervention if necessary.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
- Histologically confirmed FIGO grade 3 endometrioid or mucinous carcinoma or high grade serous, clearcell, undifferentiated or dedifferentiated carcinoma or mixed cell adenocarcinoma or carcinosarcoma
- Surgery performed within 5 weeks of randomisation
- Written informed consent
- No prior anticancer therapy for endometrial cancer
- ECOG status 0-2
- Life expectancy of at least 3 months
- Age 18 and above
-Adequate renal, hepatic and bene marrow tunetion
- Adjuvant treatment to commence within 8 weeks of surgery
- Willingness to complete Quality of Life Questionnaires
Exclusion criteria
- Grossly enlarged nodes (1Omm or largeronshort axis) on pre operative scanning
- Metastatic disease seen outside the uterus on pre operative scanning
- Separate malignancy in last 5 years
- Small cell carcinoma with neuroendocrine differentiation
- Concurrent cancer therapy
- Previous or concurrent malignant disease except carcinoma in situ of cervix, or non-melanoma skin cancer, basal cell carcinoma and melanoma in situ.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02566811 |
| CCMO | NL63569.042.17 |