PURPOSE: 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 alpha=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 alpha=0.05. Equivalence will be assumed if the difference in DFS does not exceed 7% 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.
RCT Entities:
PURPOSE: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 alpha=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 alpha=0.05. Equivalence will be assumed if the difference in DFS does not exceed 7% 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.
Authors: Tim Wollinga; Nicole P M Ezendam; Florine A Eggink; Marieke Smink; Dennis van Hamont; Brenda Pijlman; Erik Boss; Elisabeth J Robbe; Huy Ngo; Dorry Boll; Constantijne H Mom; Maaike A van der Aa; Roy F L P Kruitwagen; Hans W Nijman; Johanna M A Pijnenborg Journal: Gynecol Surg Date: 2018-02-27
Authors: Josefa Marcos-Sanmartín; José Antonio López Fernández; José Sánchez-Payá; Óscar Cruz Piñero-Sánchez; María José Román-Sánchez; María Asunción Quijada-Cazorla; María Amparo Candela-Hidalgo; Juan Carlos Martínez-Escoriza Journal: Int J Gynecol Cancer Date: 2016-11 Impact factor: 3.437