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Total Laparoscopic Versus Open Surgery for Stage 1 Endometrial Cancer: The LACE Randomized Controlled Trial

Janda, Monika, Gebski, Val, Forder, Peta, Jackson, Dan, Williams, Gail, & Obermair, Andreas (2006) Total Laparoscopic Versus Open Surgery for Stage 1 Endometrial Cancer: The LACE Randomized Controlled Trial. Contemporary Clinical Trials, 27(4), pp. 353-363.

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Abstract

Endometrial cancer is the most common gynaecological malignancy in Australia and the US. Current standard treatment involves open surgery to remove the uterus, and both tubes and ovaries (TAH). The Laparoscopic Approach to Cancer of the Endometrium (LACE) trial was designed to assess equivalence of performing this in a total laparoscopic approach (TLH). Methods: Patient recruitment was designed to proceed along two stages to accommodate for a potential increase in patient requests of laparoscopic surgery. During the first stage, patients are randomised in a 2:1 allocation to receive TLH or TAH, with the primary endpoint quality of life (QoL) at 6 month post-surgery, requiring 180 patients to be enrolled to have 80% power at α = 0.05 to detect a clinically significant difference of 8 points on the Functional Assessment of Cancer General (FACT-G) QoL instrument. If additional recruitment of patients seems impossible after accrual of 180 patients, this cohort will be followed for 4 years, and disease free survival (DFS) of patients treated by TLH will be compared to DFS within the endometrial cancer population. During the second stage, recruitment will be extended to a total of 590 patients in a 1:1 TLH: TAH allocation, to assess the equivalence with respect to DFS with 80% power and α = 0.05. Equivalence will be assumed if the difference in DFS does not exceed 7 per cent at 4 years. Secondary outcomes include treatment related morbidity; costs and cost-effectiveness; patterns of recurrence; and overall survival. All data from this multicentre study will be entered using online electronic case report forms (e-CRF), allowing real time assessment of data completeness and patient follow-up. Conclusions: The LACE trial will establish the equivalence of a TLH approach for patients with stage 1 endometrial cancer following a two stage protocol to accommodate potential threats to patient recruitment through requests for laparoscopic surgery.

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ID Code: 7251
Item Type: Journal Article
Additional Information: For more information please refer to the publisher's website (link above) or contact the author: m.janda@qut.edu.au
Keywords: Endometrial Cancer, Laparoscopic Surgery, Phase III Clinical Trial, Quality of Life, Body Image
DOI: 10.1016/j.cct.2006.03.004
ISSN: 1551-7144
Subjects: Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > PUBLIC HEALTH AND HEALTH SERVICES (111700)
Divisions: Current > Research Centres > Centre for Health Research
Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Funding:
  • NHMRC CDA /553034
Copyright Owner: Copyright 2006 Elsevier
Deposited On: 30 Apr 2007
Last Modified: 22 Jul 2014 16:26

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