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Laparoscopic Approach to Cancer of the Endometrium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00096408
Recruitment Status : Active, not recruiting
First Posted : November 9, 2004
Last Update Posted : September 28, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

November 9, 2004
November 9, 2004
September 28, 2016
October 2005
April 2016   (Final data collection date for primary outcome measure)
Disease free survival [ Time Frame: 4.5 years from surgery ]
Quality of Life (QoL) measured preoperative at 1 week, 1 month, 3 months and 6 months postoperative.
Complete list of historical versions of study NCT00096408 on ClinicalTrials.gov Archive Site
  • Intra/Peri/Post-operative and long-term morbidity [ Time Frame: 30 days from surgery ]
  • Patterns of recurrence [ Time Frame: 4.5 years from surgery ]
  • Pain and analgesia [ Time Frame: 1 week, 1 month, 3 months and 6 months postoperative. ]
  • Quality of Life [ Time Frame: Measured at baseline, then again 1 week, 6 weeks, 3 months and 6 months postoperatively. ]
Intra/Peri/Post-operative and long-term morbidity; Patterns of recurrence; transfusion requirements; Pain and analgesia
Not Provided
Not Provided
 
Laparoscopic Approach to Cancer of the Endometrium
LACE - Laparoscopic Approach to Cancer of the Endometrium: An International Multicenter Randomized Phase 3 Clinical Trial
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).

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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Endometrial Cancer
  • 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
  • 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 Name: Keyhole hysterectomy
  • Active Comparator: 1
    Total Abdominal Hysterectomy
    Intervention: Procedure: Total Abdominal Hysterectomy
  • Experimental: 2
    Total Laparoscopic Hysterectomy
    Intervention: Procedure: Total Laparoscopic Hysterectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
760
December 2018
April 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Hong Kong,   New Zealand,   United Kingdom
Belgium
 
NCT00096408
LACE001
Yes
Not Provided
Plan to Share IPD: Undecided
Queensland Centre for Gynaecological Cancer
Queensland Centre for Gynaecological Cancer
  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  • Tyco Healthcare Group
  • Gynetech
  • Queensland Government - Smart Health Research Grant
  • National Health and Medical Research Council, Australia
  • Cancer Council Queensland
  • Cancer Council New South Wales
  • Cancer Council Victoria
  • Cancer Council Western Australia
  • Cancer Australia
Principal Investigator: Andreas Obermair Queensland Centre for Gynaecological Cancer
Queensland Centre for Gynaecological Cancer
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP