cancer of the uterus Endometrial cancer
Conditions
Interventions
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 wil
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Netherlands
Outcome results
None listed