Laparoscopic Approach to Cancer of the Endometrium

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096408
• Other study ID #: LACE001
• Status: Completed
• Phase: Phase 3
• Start date: October 2005
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Queensland Centre for Gynaecological Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 760
• Est. completion date: December 2018
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Wesley Hospital	Auchenflower	Queensland
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Royal Women's Hospital	Carlton	Victoria
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Greenslopes Private Hospital	Greenslopes	Queensland
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Cabrini Health	Malvern	Victoria
Australia	John Hunter Hospital	New Lambton	New South Wales
Australia	Newcastle Private Hospital	New Lambton Heights	New South Wales
Australia	King Edward Memorial Hospital for Women	Perth	Western Australia
Australia	Royal Hospital for Women	Randwick	New South Wales
Australia	Mater Adult Public Hospital	South Brisbane	Queensland
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	St John of God Hospital	Subiaco	Western Australia
Australia	Mater Misericordiae Hospital Townsville	Townsville	Queensland
Australia	Townsville Hospital	Townsville	Queensland
Australia	Westmead Hospital	Westmead	New South Wales
Hong Kong	Queen Mary Hospital	Pok Fu Lam
New Zealand	Christchurch Women's Hospital	Christchurch	Canterbury
New Zealand	Oxford Clinic Women's Health	Christchurch
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh

Sponsors (11)

Lead Sponsor	Collaborator
Queensland Centre for Gynaecological Cancer	Cancer Australia, Cancer Council New South Wales, Cancer Council Queensland, Cancer Council Victoria, Cancer Council Western Australia, Gynetech, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., National Health and Medical Research Council, Australia, Queensland Government - Smart Health Research Grant, Tyco Healthcare Group

Countries where clinical trial is conducted

Australia,  Hong Kong,  New Zealand,  United Kingdom, 

References & Publications (1)

Janda M, Gebski V, Forder P, Jackson D, Williams G, Obermair A; LACE Trial Committee. Total laparoscopic versus open surgery for stage 1 endometrial cancer: the LACE randomized controlled trial. Contemp Clin Trials. 2006 Aug;27(4):353-63. Epub 2006 May 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		4.5 years from surgery
Secondary	Intra/Peri/Post-operative and long-term morbidity		30 days from surgery
Secondary	Patterns of recurrence		4.5 years from surgery
Secondary	Pain and analgesia		1 week, 1 month, 3 months and 6 months postoperative.
Secondary	Quality of Life		Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively.

External Links

•   Gynaecological Oncology website
•   QCGC Research