Laparoscopic Approach to Cancer of the Endometrium
- Conditions
- Endometrial Cancer
- Interventions
- Procedure: Total Abdominal HysterectomyProcedure: Total Laparoscopic Hysterectomy
- Registration Number
- NCT00096408
- Lead Sponsor
- Queensland Centre for Gynaecological Cancer
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 760
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Total Abdominal Hysterectomy Total Abdominal Hysterectomy 2 Total Laparoscopic Hysterectomy Total Laparoscopic Hysterectomy
- Primary Outcome Measures
Name Time Method Disease free survival 4.5 years from surgery
- Secondary Outcome Measures
Name Time Method Intra/Peri/Post-operative and long-term morbidity 30 days from surgery Quality of Life Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively. Patterns of recurrence 4.5 years from surgery Pain and analgesia 1 week, 1 month, 3 months and 6 months postoperative.
Trial Locations
- Locations (23)
Cabrini Health
🇦🇺Malvern, Victoria, Australia
King Edward Memorial Hospital for Women
🇦🇺Perth, Western Australia, Australia
John Hunter Hospital
🇦🇺New Lambton, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
The Wesley Hospital
🇦🇺Auchenflower, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Royal Hospital for Women
🇦🇺Randwick, New South Wales, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Oxford Clinic Women's Health
🇳🇿Christchurch, New Zealand
Newcastle Private Hospital
🇦🇺New Lambton Heights, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Greenslopes Private Hospital
🇦🇺Greenslopes, Queensland, Australia
Mater Adult Public Hospital
🇦🇺South Brisbane, Queensland, Australia
Mater Misericordiae Hospital Townsville
🇦🇺Townsville, Queensland, Australia
Townsville Hospital
🇦🇺Townsville, Queensland, Australia
Royal Women's Hospital
🇦🇺Carlton, Victoria, Australia
St John of God Hospital
🇦🇺Subiaco, Western Australia, Australia
Christchurch Women's Hospital
🇳🇿Christchurch, Canterbury, New Zealand
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Queen Mary Hospital
🇭🇰Pok Fu Lam, Hong Kong