PlaComOv-study: PlasmaJet in case of Ovarian Cancer

Background information

The most important goal for survival benefit of advanced stage ovarian cancer is to surgically remove all visible tumour, because complete cytoreductive surgery (CCS) is associated with prolonged survival. In a remarkable number of women, CCS is very challenging. Especially if many small metastases are present, conventional CCS with electrosurgery is not able to be “complete” in safely removing all visible tumour. In this randomized controlled trial we investigate whether the use of the PlasmaJet surgical device increases the rate of CCS, and whether this indeed leads to a longer progression-free survival and overall survival

Overall aim

Three hundred and thirty women undergoing cytoreductive surgery for ovarian carcinoma FIGO Stage IIIB-IV will be randomized into two study arms: use of the PlasmaJet (intervention group) versus the use of standard surgical instruments combined with electrocoagulation (control group).The primary outcome is the rate of complete cytoreductive surgery.

Secondary study objectives are: 30-day morbidity, duration of surgery, blood loss, length of hospitalisation, quality of life, disease-free survival, overall survival, percentage of colostomies, and cost-effectiveness. Quality of life will be evaluated using validated questionnaires at baseline, at 1 and 6 months after surgery and at 1, 2, 3 and 4 years after surgery.

Funding

The study is funded by the Netherlands Organization for Health Research and Development (ZonMw). PlasmaSurgical and Medical Dynamics each provide an in-kind subsidy: the loan and maintenance of the PlasmaJet systems. Neither company was involved in the study design and none will be involved in the collection, analysis or interpretation of data, nor in the writing of the manuscripts or in the decisions to submit manuscripts for publication.

• The Netherlands Organization for Health Research and Development ZonMw
• Plasma Surgical and Medical Dynamics provide an in-kind subsidy.

Collaboration within Erasmus MC

• Department of Radiology & Nuclear Medicine
• Department of Pathology
• ACE Gynaecological Tumours

Collaboration outside of Erasmus MC

The study is a multicentre, single-blinded superiority RCT in two university and nine  non-university hospitals in the Netherlands. Patients with a FIGO IIIB-IV ovarian carcinoma from the following Dutch hospitals may be included:

• Albert Schweitzer (Dordrecht).
• Bravis (Bergen op Zoom).
• Catharina Cancer Institute (Eindhoven).
• Erasmus MC (Rotterdam).
• Franciscus Gasthuis and Vlietland (Rotterdam).
• Groene Hart Hospital (Gouda).
• Haags Medisch Centrum (Den Haag).
• Haga Hospital (Den Haag).
• Leids University MC (Leiden).
• Medisch Spectrum Twente (Enschede).
• Reinier de Graaf Groep (Delft).

Evaluation of effectiveness of the PlasmaJet surgical device in the treatment of advanced stage ovarian cancer (PlaComOv-study): study protocol of a randomized controlled trial in the Netherlands.
G.M. Nieuwenhuyzen-de Boer, W. Hofhuis, N. Reesink-Peters, P.C. Ewing-Graham, I.G. Schoots, J.J. Beltman, J.M.J. Piek, A. Baalbergen, G.S. Kooi, A. van Haaften, H. van Huisseling, L. Haans, M. Dorman, H.J. van Beekhuizen. (2019) BMC Cancer. 2019 Jan 14;19(1):58.

• Gatske M. Nieuwenhuyzen-de Boer
• Heleen J. van Beekhuizen
• Patricia C. Ewing
• Ivo G. Schoots
• Ward Hofhuis
• Nathalie Reesink-Peters
• Jogchum J. Beltman
• Jurgen M.J. Piek
• Astrid Baalbergen
• Lisette N. Hofman
• Annemarie van Haaften
• Ileana Nedelcu
• Lucien Haans
• Manja Dorman