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 full lymph 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
Progression-free survival
Side effects:
- of surgery (using Dindo classification)
- of chemotherapy/radiotherapy (using NCI common terminology for adverse events)
Quality of life (EORTC QLQ C-30 and EN24 module voor endometrial cancer)
Cost effectiveness ((EQ-5D-5L)
Background summary
Endometrial cancer is the most common 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 women with
high risk of recurrent disease will be offered further treatment. This study
will demonstrate the optimal surgical treatment and use of adjuvant therapy for
women with high risk stage 1 endometrial cancer, resulting in elimination of
the wide variation in practice 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 full lymph node
dissection.
Study design
Randomised, non-inferiority multicentre trial. Patients will be recruited in
the Unites States, 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-aortic lymph node dissection, or no node
dissection. All women in the unstaged arm will receive adjuvant therapy due to
the risk of node involvement and/or relapse of 15-20%. In the staged arm, only
women with positive nodes will 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 represent 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 follow-up procedures will be performed during regular follow-up
appointments. Patients with negative nodes will not receive
chemotherapy/radiation and therefore will not face the well known side effects
associated with this standard adjuvant treatment. We acknowledge that there may
be a very small chance that these patients, who have not undergone adjuvant
therapy, may face an increased risk of recurrence of the disease. Frequent
check-ups will ensure rapid detection and intervention if necessary
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
- Histologically confirmed grade 3 endometrial carcinoma, serous, clearcell or carcinosarcoma
- Grade 2 endometrioid carcinoma if LVSI is confirmed on histology, or deep invasion into the myometrium is demonstrated at preoperative MRI, or post operative hysterectomy specimen if randomisation is occuring at this point
- Surgery performed within 5 weeks of randomisation
- Written informed consent
- No prior anticancer therapy for endometrial cancer
- ECOG status 0-2
- No concomitant cancer
- Life expectancy of at least 3 months
- Age 18 and above
- Adequate renal, hepatic and bone marrow function
- Adjuvant treatment to commence within 8 weeks of surgery
- Willingness to complete Quality of Life Questionnaires
Exclusion criteria
- Grossly enlarged nodes 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 and basal cell carcinoma.
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 |
|---|---|
| CCMO | NL49874.042.14 |