Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy

Women with advanced stage epithelial ovarian cancer are treated with a
combination of chemotherapy (Carboplatin and Paclitaxel) and an operation with
the aim to remove all visible tumor. With this surgery at least the uterus,
ovaries and omentum are removed. But depending on the extent of the disease the
surgery may also include removal of part of the bowel, the spleen, the
peritoneum covering the abdominal wall and diaphragm, etc. . The standard
approach for this type of surgery is a median laparotomy with an incision from
the symphysis up to, in some cases, the xiphoid.

For the treatment sometimes it is decided to start with this surgery, a so
called primary debulking. An alternative approach is to start with neoadjuvant
chemotherapy with the aim to reduce the tumor load which will lead to a more
limited dissection. This research will focus on this last group.

For women treated with neoadjuvant chemotherapy tumor response will be
evaluated with a CT scan after two or three cycles of chemotherapy. At
debulking surgery all identified tumor deposits will be removed. The advantage
of a laparotomy is that it gives good access to the abdominal cavity with good
visibility and the ability to feel for tumor deposits. A laparotomy is
therefore still considered standard of care.

However, there is considerable experience with the use of laparoscopic surgery
in gynaecologic oncology. For endometrial cancer the laparoscopic approach is
standard of care. For early stage ovarian cancer laparoscopic surgery is also
the preferred approach. The advantage of laparoscopy is faster recovery with
less blood loss en reduced pain.

The primary objective of this study is to examine whether MIS is non-inferior
to laparotomy in terms of disease free survival (DFS) in women with advanced
stage EOC that received 3 to 4 cycles of NACT.

The study is an international, prospective, randomized, multicenter,
non-inferiority phase III trial

Laparoscopic cytoreductive surgery

Both laparoscopic and open surgery are used in gynaecologic oncologic surgery.
Women often recover quicker after a laparoscopic procedure. The risk of this
study is that small tumordeposits are missed that would have been identified
with a open procedure which may possibly lead to a worse oncologic outcome. We
expect this risk to be small as the inclusion criteria are very restrictive and
only allow participation of women who have shown to have a very good repsonse
aftre neoadjuvant chemotherapy.

The follow up is comparable with the standard of care with the exeption of two
additional visits after 3,5 and 4,5 years.