Laparoscopic Approach to Cancer of the Endometrium

Sponsor

Queensland Centre for Gynaecological Cancer (Other)

Overall Status

Completed

CT.gov ID

NCT00096408

Collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry), Tyco Healthcare Group (Industry), Gynetech (Industry), Queensland Government - Smart Health Research Grant (Other), National Health and Medical Research Council, Australia (Other), Cancer Council Queensland (Other), Cancer Council New South Wales (Other), Cancer Council Victoria (Other), Cancer Council Western Australia (Other), Cancer Australia (Other)

760

Enrollment

Locations

Arms

158

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Procedure: Total Abdominal Hysterectomy Procedure: Total Laparoscopic Hysterectomy	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

760 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Total Abdominal Hysterectomy	Procedure: Total Abdominal Hysterectomy For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia. Other Names: TAH Open hysterectomy
Experimental: 2 Total Laparoscopic Hysterectomy	Procedure: Total Laparoscopic Hysterectomy 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. Other Names: Keyhole hysterectomy

Arm

Intervention/Treatment

Active Comparator: 1

Total Abdominal Hysterectomy

Procedure: Total Abdominal Hysterectomy

For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia.

Other Names:

TAH

Open hysterectomy

Experimental: 2

Total Laparoscopic Hysterectomy

Procedure: Total Laparoscopic Hysterectomy

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.

Other Names:

Keyhole hysterectomy

Outcome Measures

Primary Outcome Measures

Disease free survival [4.5 years from surgery]

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
2	Newcastle Private Hospital	New Lambton Heights	New South Wales	Australia	2305
3	John Hunter Hospital	New Lambton	New South Wales	Australia	2305
4	Royal Hospital for Women	Randwick	New South Wales	Australia	2031
5	Royal North Shore Hospital	St Leonards	New South Wales	Australia	2065
6	Westmead Hospital	Westmead	New South Wales	Australia	2050
7	The Wesley Hospital	Auchenflower	Queensland	Australia	4066
8	Greenslopes Private Hospital	Greenslopes	Queensland	Australia	4120
9	Royal Brisbane and Women's Hospital	Herston	Queensland	Australia	4029
10	Mater Adult Public Hospital	South Brisbane	Queensland	Australia	4101
11	Mater Misericordiae Hospital Townsville	Townsville	Queensland	Australia	4810
12	Townsville Hospital	Townsville	Queensland	Australia	4810
13	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
14	Box Hill Hospital	Box Hill	Victoria	Australia	3128
15	Royal Women's Hospital	Carlton	Victoria	Australia	3168
16	Monash Medical Centre	Clayton	Victoria	Australia	3168
17	Cabrini Health	Malvern	Victoria	Australia	3144
18	King Edward Memorial Hospital for Women	Perth	Western Australia	Australia	6008
19	St John of God Hospital	Subiaco	Western Australia	Australia	6904
20	Queen Mary Hospital	Pok Fu Lam		Hong Kong
21	Christchurch Women's Hospital	Christchurch	Canterbury	New Zealand
22	Oxford Clinic Women's Health	Christchurch		New Zealand
23	Royal Infirmary of Edinburgh	Edinburgh		United Kingdom