None listed
Conditions
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.
Interventions
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
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.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed