NCT00096408

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
760

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_3

Geographic Reach
4 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

10.5 years

First QC Date

November 9, 2004

Last Update Submit

March 18, 2019

Conditions

Endometrial Cancer

Keywords

EndometrialEndometriumUterusCancerCarcinomaAdenocarcinomaStage 1HysterectomyLaparoscopyAbdominalTotalSurgeryQuality of LifeDisease-free survival

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    4.5 years from surgery

Secondary Outcomes (4)

  • 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.

Study Arms (2)

1

ACTIVE COMPARATOR

Total Abdominal Hysterectomy

Procedure: Total Abdominal Hysterectomy

2

EXPERIMENTAL

Total Laparoscopic Hysterectomy

Procedure: Total Laparoscopic Hysterectomy

Interventions

Total Abdominal HysterectomyPROCEDURE

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

Also known as: TAH, Open hysterectomy
1
Total Laparoscopic HysterectomyPROCEDURE

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.

Also known as: Keyhole hysterectomy
2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

John Hunter Hospital

New Lambton, New South Wales, 2305, Australia

Location

Newcastle Private Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

Royal Hospital for Women

Randwick, New South Wales, 2031, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2050, Australia

Location

The Wesley Hospital

Auchenflower, Queensland, 4066, Australia

Location

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Adult Public Hospital

South Brisbane, Queensland, 4101, Australia

Location

Mater Misericordiae Hospital Townsville

Townsville, Queensland, 4810, Australia

Location

Townsville Hospital

Townsville, Queensland, 4810, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Royal Women's Hospital

Carlton, Victoria, 3168, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Cabrini Health

Malvern, Victoria, 3144, Australia

Location

King Edward Memorial Hospital for Women

Perth, Western Australia, 6008, Australia

Location

St John of God Hospital

Subiaco, Western Australia, 6904, Australia

Location

Queen Mary Hospital

Pok Fu Lam, Hong Kong

Location

Christchurch Women's Hospital

Christchurch, Canterbury, New Zealand

Location

Oxford Clinic Women's Health

Christchurch, New Zealand

Location

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (6)

  • 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. doi: 10.1016/j.cct.2006.03.004. Epub 2006 May 5.

    PMID: 16678497BACKGROUND

  • Gebski V, Obermair A, Janda M. Toward Incorporating Health-Related Quality of Life as Coprimary End Points in Clinical Trials: Time to Achieve Clinical Important Differences and QoL Profiles. J Clin Oncol. 2022 Jul 20;40(21):2378-2388. doi: 10.1200/JCO.21.02750. Epub 2022 May 16.

    PMID: 35576502DERIVED

  • Janda M, Gebski V, Davies LC, Forder P, Brand A, Hogg R, Jobling TW, Land R, Manolitsas T, Nascimento M, Neesham D, Nicklin JL, Oehler MK, Otton G, Perrin L, Salfinger S, Hammond I, Leung Y, Sykes P, Ngan H, Garrett A, Laney M, Ng TY, Tam K, Chan K, Wrede CD, Pather S, Simcock B, Farrell R, Robertson G, Walker G, Armfield NR, Graves N, McCartney AJ, Obermair A. Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free Survival Among Women With Stage I Endometrial Cancer: A Randomized Clinical Trial. JAMA. 2017 Mar 28;317(12):1224-1233. doi: 10.1001/jama.2017.2068.

    PMID: 28350928DERIVED

  • Belavy D, Janda M, Baker J, Obermair A. Epidural analgesia is associated with an increased incidence of postoperative complications in patients requiring an abdominal hysterectomy for early stage endometrial cancer. Gynecol Oncol. 2013 Nov;131(2):423-9. doi: 10.1016/j.ygyno.2013.08.027. Epub 2013 Sep 3.

    PMID: 24007947DERIVED

  • Kondalsamy-Chennakesavan S, Janda M, Gebski V, Baker J, Brand A, Hogg R, Jobling TW, Land R, Manolitsas T, Nascimento M, Neesham D, Nicklin JL, Oehler MK, Otton G, Perrin L, Salfinger S, Hammond I, Leung Y, Sykes P, Ngan H, Garrett A, Laney M, Ng TY, Tam K, Chan K, Wrede DH, Pather S, Simcock B, Farrell R, Robertson G, Walker G, McCartney A, Obermair A. Risk factors to predict the incidence of surgical adverse events following open or laparoscopic surgery for apparent early stage endometrial cancer: results from a randomised controlled trial. Eur J Cancer. 2012 Sep;48(14):2155-62. doi: 10.1016/j.ejca.2012.03.013. Epub 2012 Apr 12.

    PMID: 22503396DERIVED

  • Janda M, Gebski V, Brand A, Hogg R, Jobling TW, Land R, Manolitsas T, McCartney A, Nascimento M, Neesham D, Nicklin JL, Oehler MK, Otton G, Perrin L, Salfinger S, Hammond I, Leung Y, Walsh T, Sykes P, Ngan H, Garrett A, Laney M, Ng TY, Tam K, Chan K, Wrede CD, Pather S, Simcock B, Farrell R, Obermair A. Quality of life after total laparoscopic hysterectomy versus total abdominal hysterectomy for stage I endometrial cancer (LACE): a randomised trial. Lancet Oncol. 2010 Aug;11(8):772-80. doi: 10.1016/S1470-2045(10)70145-5. Epub 2010 Jul 16.

    PMID: 20638899DERIVED

Related Links

MeSH Terms

Conditions

Endometrial NeoplasmsNeoplasmsCarcinomaAdenocarcinoma

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Andreas Obermair

    Queensland Centre for Gynaecological Cancer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 9, 2004

Study Start

October 1, 2005

Primary Completion

April 1, 2016

Study Completion

December 1, 2018

Last Updated

March 20, 2019

Record last verified: 2019-03

Locations

HK(1)AU(19)GB(1)NZ(2)