Selective Targeting of Adjuvant Therapy for Endometrial Cancer (STATEC) — STATEC  

Endometrial Cancer Clinical Trial

Official title: A Randomised Trial of Non-selective Versus Selective Adjuvant Therapy in High Risk Apparent Stage 1 Endometrial Cancer

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

Results from this trial have the potential to change practice whatever the results: either lymphadenectomy will become recommended practice if a non-inferior outcome is obtained; otherwise the procedure can be safely abandoned.

Secondary Objectives

• Disease-free, endometrial cancer-event free and endometrial cancer-specific survival

• Distribution of pelvic and extra-pelvic relapse

• Cost effectiveness

• Surgical adverse events

There are also two sub-studies:

1. Quality of life - all patients i. Describe the trajectory of key patient reported outcomes (PROs) from baseline up to 5 years post-surgery ii. Compare the specific PRO domains between the trial arms at several specific time points iii. Determine the proportion of women in each trial arm reporting long-term symptoms after treatment as measured by the symptom-specific subscales of the measures (gastrointestinal symptoms, urological symptoms, attitude to disease and treatment, vaginal symptoms, lymphoedema) iv. Determine the correlation between physician rating (CTCAE v4.03) and patient-report (corresponding PRO subscale) for various symptoms reported by both physicians and patients v. Assess the correlation between self-assessed lymphoedema (Self-report lower-extremity lymphoedema screening questionnaire) and the lymphoedema subscale of the Quality of Life Questionnaire-Endometrial Cancer Module (QLQ-EN24)

We hypothesise that quality of life will be better in patients in the lymphadenectomy arm because a considerable proportion will be spared systemic adjuvant treatment, from which they may not benefit.

2. Sentinel lymph node (SLN) - optional for Arm 1 patients

The aim of this sub-study is to assess SLN status in comparison with the overall lymph node status after full lymph node dissection (LND), and so determine whether SLN is as accurate as systematic node dissection.

i. We aim to determine the diagnostic performance of the SLN procedure compared to the gold standard of LND ii. To evaluate whether SLN status is a prognostic marker of survival iii. To model patient relapse and survival based on low volume micro-metastatic (LVM) and individual tumour cell (ITC) status ;

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

• NCT number: NCT02566811
• Study type: Interventional
• Source: University College, London
• Status: Terminated
• Phase: N/A
• Start date: April 12, 2017
• Completion date: August 14, 2019