Laparoscopic Approach to Cancer of the Endometrium

Study Overview
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Brief Summary
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The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who are randomised to receive Total Laparoscopic Hysterectomy (TLH) and patients who are randomised to receive Total Abdominal Hysterectomy (TAH).

Detailed Description
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This phase III international, multicenter, open-label, randomized clinical trial is an equivalence study with the hypothesis is that Total Laparoscopic Hysterectomy (TLH) is associated with equivalent disease-free survival when compared to the standard treatment of Total Abdominal Hysterectomy (TAH) for women with apparent Stage I endometrial cancer. The secondary hypotheses are: TLH is associated with equivalent or improved Quality of Life (QoL) at 6 months; TLH is associated with reduced treatment-related morbidity; TLH is associated with shorter hospital stay; TLH is associated with less analgesic consumption; TLH is cost effective; TLH is associated with improved pelvic floor function.

Official Title
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LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Procedure: Total Abdominal Hysterectomy
* Procedure: Total Laparoscopic Hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who may be included for this study must have the following: Histologically confirmed primary endometrioid adenocarcinoma of the endometrium; Clinical stage I disease; ECOG Performance status of 0-1; Signed written informed consent; Females, aged 18 years or older. Exclusion Criteria: Patients will be excluded from participating from the study if they have any of the following: Other histologic type than endometrioid adenocarcinoma of the endometrium; Clinically advanced disease (stages II-IV); Uterine size larger than 10 weeks gestation; Estimated life expectancy of less than 6 months; Enlarged aortic lymph nodes; Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator); Patient compliance and geographic proximity that does not allow adequate follow-up; Unfit to complete QoL measurements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Total Abdominal Hysterectomy | Procedure: Total Abdominal Hysterectomy<br>* For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia.<br>* Other names: Open hysterectomy;|
| Experimental: 2<br>Total Laparoscopic Hysterectomy | Procedure: Total Laparoscopic Hysterectomy<br>* The technique of total laparoscopic hysterectomy (TLH), utilising the McCartney tube, has been developed by Anthony J. McCartney over the last 10 years. It allows the completion of the hysterectomy entirely laparoscopically, without the need for additional vaginal surgery.<br>* Other names: Keyhole hysterectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 4.5 years from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra/Peri/Post-operative and long-term morbidity |  | 30 days from surgery | 
| Patterns of recurrence |  | 4.5 years from surgery | 
| Pain and analgesia |  | 1 week, 1 month, 3 months and 6 months postoperative. | 
| Quality of Life |  | Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial, Endometrium, Uterus, Cancer, Carcinoma, Adenocarcinoma, Stage 1, Hysterectomy, Laparoscopy, Abdominal, Total, Surgery, Quality of Life, Disease-free survival