Clinical trial · Interventional
Selective Targeting of Adjuvant Therapy for Endometrial Cancer (STATEC)
A Randomised Trial of Non-selective Versus Selective Adjuvant Therapy in High Risk Apparent Stage 1 Endometrial Cancer
NCT02566811CI-TRIAL-00040910STATECterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawal of funding by CR UK due to poor recruitment
Summary
Brief summary (as posted)
The primary aim of this trial is to determine whether lymphadenectomy, used to restrict adjuvant therapy (other than vaginal brachytherapy) to node positive women, results in a non-inferior survival as compared to adjuvant therapy given to all women with high risk apparent stage 1 endometrial cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abdominal surgery | Procedure | — | UNRESOLVED |
| Lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abdominal surgery with lymphadenectomy
- description
- Patients will receive a hysterectomy and bilateral salpingo-oophorectomy (BSO)\* with lymph node dissection to determine whether lymph nodes are positive or negative: Positive: patients will receive systemic adjuvant treatment to include chemotherapy Negative: patients will receive vaginal brachytherapy only Patients will then be followed up, to include assessment of adverse events and quality of life. \*There is an option for patients to be randomised following a pre-trial hysterectomy and BSO. If randomised to this arm, the lymph node dissection will be performed as a separate procedure.
- interventionNames
- Procedure: Abdominal surgery
- Procedure: Lymphadenectomy
- type
- ACTIVE_COMPARATOR
- label
- Abdominal surgery, no lymphadenectomy
- description
- Patients will receive a hysterectomy and bilateral salpingo-oophorectomy (BSO)\*. Patients will receive systemic adjuvant treatment to include chemotherapy. Patients will then be followed up, to include assessment of adverse events and quality of life. \*There is an option for patients to be randomised following a pre-trial hysterectomy and BSO. If randomised to this arm, no further surgery will be given and the patient will proceed to receive systemic adjuvant treatment to include chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
Show eligibility criteria text
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: 1. FIGO grade 3 endometrioid or mucinous carcinoma 2. 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: 1. carcinoma in situ of cervix 2. non-melanoma skin cancer 3. basal cell carcinoma 4. melanoma in situ * Women who are pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.