Laparoscopic Approach to Cancer of the Endometrium

NCT00096408CompletedPHASE3INTERVENTIONAL

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).

Key Facts

Lead Sponsor

Queensland Centre for Gynaecological Cancer

Enrollment

760

Start Date

2005-10-01

Completion Date

2016-04-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Total Abdominal HysterectomyTotal Laparoscopic Hysterectomy

Conditions

Endometrial Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Disease free survival

Time frame: 4.5 years from surgery

Secondary Outcomes

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.

Locations

Royal Prince Alfred Hospital, Camperdown, Australia

John Hunter Hospital, New Lambton, Australia

Newcastle Private Hospital, New Lambton Heights, Australia

Royal Hospital for Women, Randwick, Australia

Royal North Shore Hospital, St Leonards, Australia

Westmead Hospital, Westmead, Australia

The Wesley Hospital, Auchenflower, Australia

Greenslopes Private Hospital, Greenslopes, Australia

Royal Brisbane and Women's Hospital, Herston, Australia

Mater Adult Public Hospital, South Brisbane, Australia

Mater Misericordiae Hospital Townsville, Townsville, Australia

Townsville Hospital, Townsville, Australia

Royal Adelaide Hospital, Adelaide, Australia

Box Hill Hospital, Box Hill, Australia

Royal Women's Hospital, Carlton, Australia

Monash Medical Centre, Clayton, Australia

Cabrini Health, Malvern, Australia

King Edward Memorial Hospital for Women, Perth, Australia

St John of God Hospital, Subiaco, Australia

Queen Mary Hospital, Pok Fu Lam, Hong Kong

Christchurch Women's Hospital, Christchurch, New Zealand

Oxford Clinic Women's Health, Christchurch, New Zealand

Royal Infirmary of Edinburgh, Edinburgh, United Kingdom

Linked Papers

2022-05-16

Toward Incorporating Health-Related Quality of Life as Coprimary End Points in Clinical Trials: Time to Achieve Clinical Important Differences and QoL Profiles

PURPOSE Besides morbidity and mortality, quality of life (QoL) is a key outcome of cancer treatments. Trials on the basis of clinical outcomes have expectations that QoL outcomes can be either tolerated or improved. Simultaneously considering QoL and clinical outcomes is challenging with lack of suitable metrics allowing incorporation of QoL as coprimary end points in clinical trial design and utilization of hierarchical hypothesis testing. METHOD We propose combining time to achieving a minimal clinically important difference (MCID) and probabilities of a MCID occurring in each QoL domain to provide QoL metrics analogous to those used for clinical end points. For QoL domains of interest, these yield QoL profiles, time to MCID, and number needed to treat. Incorporation of QoL as coprimary end points in clinical trial designs through hierarchical hypothesis testing can easily be achieved. The noninferiority designed Laparoscopic Approach to Carcinoma of the Endometrium trial, evaluating laparoscopic versus open abdominal surgery for endometrial cancer with Functional Assessment of Cancer Therapy–General QoL domains, is used to illustrate the usefulness of these metrics. RESULTS This analysis revealed that laparoscopic surgery had a significant shorter time to MCID for physical and functional well-being QoL domains (physical mean: 1.5 months, 95% CI, 0.5 to 2.6; P = .002; and functional mean: 1.4 months; 95% CI, 0.4 to 2.4; P = .003) than abdominal surgery, but little difference between the two approaches for psychologic social and emotion well-being. Probability profile plots show a consistent > 2-fold higher chance of attaining a MCID for physical and functional well-being over time for laparoscopic compared with abdominal surgery. CONCLUSION This analysis reinforces the potential value of novel MCID metrics and their usefulness in raising the profile of QoL outcomes to complement clinical end points. The methods will allow health professionals to counsel patients about QoL outcomes and clinical outcomes simultaneously.

Linked Investigators

Andreas Obermair

Monika Janda

Monika Janda is the Director of the Centre for Health Services Research, the University of Queensland, Faculty of Medicine, and Professor in Behavioural Sciences. She holds and NHMRC L3 fellowship (2025-29). She trained as clinical and health psychologist, and now has an extensive research background in cancer prevention and quality of life research. Her two main research interests are i) prevention and early detection of cancer (in particular melanoma); and ii) improving clinical and supportive care for cancer patients (in particular gynaecological cancers). In 2017, she won the Scopus highly cited researcher award for women in research. She serves on the The Australasian College of Dermatologists e-Health committee and standards committee; and served previously on the Australian Psychological Society Technology committee. She is an executive member of the Australian Skin and Skin Cancer Research Centre. She led 2019 and 2023 Melanoma Screening Summits, forging new ways towards targeted melanoma screening. She was the chair (2014-2016) of the scientific advisory committee of the psycho-oncology clinical trials group, now chairs its prevention special interest group, and was a member of the Queensland Epidemiology Group organising committee. Internationally she was an organising member of the prevention committee for the International Psycho-Oncology Society. Professor Janda has published over 200 refereed journal articles and several book chapters. Before she joined the University of Queensland in 2018, she was Principal Research Fellow with the School of Public Health and Social Work (2006-2017), and the Theme Leader Health Determinants and Health System, Institute for Health and Biomedical Innovation, Queensland University of Technology (2014-2017). Before joining QUT she was a research fellow for the Melanoma Screening trial with the Cancer Council Queensland. Prior to that she worked as a clinical Psychologist at the Department of Radiotherapy at the University Hospital Vienna, Austria.

Val Gebski

Laparoscopic Approach to Cancer of the Endometrium