LAPOVCA - studie:                   STUDIE IS GESLOTEN

Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients

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Objective
To investigate whether laparoscopy is cost-effective in predicting which patients will benefit from primary surgery and which patients should be treated with neoadjuvant chemotherapy and interval surgery instead.

Study design
A multicenter prospective randomized trial

Study population
Women between 18-80 years suspected of having advanced stage ovarian carcinoma (FIGO >IIB), who are eligle for primary debulking surgery after conventional staging and have given written informed consent

Intervention [or: Methods]
We will randomly assign patients after conventional staging to either primary surgery, without laparoscopy, or to additional laparoscopy to guide the decision between primary surgery followed by chemotherapy and neoadjuvant chemotherapy plus interval surgery

Outcome measures
Primary outcome will be futile laparotomy, defined as suboptimal primary cytoreductive surgery, when the diameter of the largest residual tumor metastasis at the end of surgery is more than 1 cm.
Secundary outcomes will be no residual tumor, less than 1 cm residual tumor after cytoreductive surgery, progression free survival, overall survival, morbidity, quality of life, days in hospital and costs.

Power/data analysis
The present rate of optimally operated patients in the Netherlands is only 37-59%. Therefore, the rate of suboptimal primary debulking after conventional staging in the Netherlands is estimated to be at most 40%, after laparoscopy this should be less than 20%. With a two-sided significance level of 0.05, and a power of 80%, 90 patients per arm have to be included. Considering 10% loss, we plan to enroll 200 patients.

Economic evaluation
The key question in the economic evaluation is to assess whether the laparoscopy can reduce the number of futile primary surgeries, and associated costs to an extent that at least offsets the costs of this laparoscopy in all eligible patients. A strategy that reduces the number of unnecessary laparotomies is considered preferable, even if this does not improve survival, also if the costs generated by both strategies are comparable.  The economic evaluation will be performed from a societal perspective including direct en indirect medical costs. We hypothesize that additional costs of laparoscopies are greatly offset by the reduced number of futile laparotomies.

Time schedule
First year: start of study in all participating centers
First 30 months: inclusion of patients, data collection and entry
Last 6 months: analysis of data, preparation of manuscripts

Projectleaders
Dr. M.R. Buist, gynaecologist-oncologist AMC Amsterdam

Study coordinator
Drs. M.J. Rutten, AMC Amsterdam

Methodology
Dr. B.C. Opmeer, clinical epidemiologist, AMC Amsterdam

Subsidy
ZonMW- www.zonmw.nl