Neo-adjuvant chemotherapy, cytoreductive surgery with hypethermic intraperitoneal chemotherapy for peritoneal carcinomatosis of colorectal origin.

Cytoreductive surgery followed by hyperthermic intra-peritoneal chemotherapy
and adjuvant systemic chemotherapy has been found to be a curative procedure in
patients with peritoneal carcinomatosis of colorectal origin. Neo-adjuvant
chemotherapy is expected to reduce tumorvolume thus facilitating cytoreduction
and offers cure to more patients

To investigate wether neo-adjuvant chemotherapy followed by cytoreductive
syurgery and hyperthermic chemotherapy is feasible and reduces the number of
irresectable patients with acceptable morbidity and mortality rates.

Non randomized observational studyconcisting of 1) phase 1 in which the
feasibility of neo-adjuvant chemotherapy followed by cytoreductive surgery an
hyperthermic intra*peritoneal chemotherapy is tested in 10 patients with regard
to safety. 2) Phase 2 in which 40 more patients are subjected to the new
neo-adjuvant chemotherapy scheme after its safety has been determined. In phase
2 we will determine the effect of the new scheme on the percentage of complete
cytoreductions.

Patients with peritoneal carcinomatosis of colorectal origin will receive 6
cycles of chemotherapy with oxaliplatin and capecitabine(CAPOX-scheme) followed
by cytoreductive surgery and hypethermic intra-peritoneal chemotherapy. After 3
cycles a CT-scan of the abdomen will be performed to evaluate the effect of the
chemotherapy. If there is a respons or stable disease 3 more cycles of
chemotherapy are given. If there is progressive disease under chemotherapy
patients will go directly for cytoreductive surgery and hyperthermic
intra-peritoneal chemotherapy mif deemed feasible by the treating surgeon.
After a complet course of chemotherapy another CT-scan will be performed, when
there is no evidence of extra-abdominal or liver metastasis patients will go
for surgery.

Patients will receive in hospital chemotherapy through an i.v line, oral
chemotherapy will be taken at home during two weeks of every cycle of
chemotherapy, regular hospital visits are required, blood samples will be taken
at every visit to evaluate the effect of chemotherapy After the chemotherapy a
period of 4 weeks to recover will be necessary. After this short period a
laparotomy from xiphoid process to the pubic tubercle will be performed to
evaluate the resectability. During that procedure, a decision will be made
whether to continue with CRS and HIPEC or not. After the operation ICU
admission will follow. Average hospital stay is expected to be 14 days
postoperatively. Risks involved with this study are the side effects of the
chemotherapy. Risks involved with the CRS and HIPEC procedure are primarily
related to the nature and extend of the surgical procedure. In case of bowel
resection with anastomosis, anastomotic dehiscence might occur. Abscess
formation, superficial wound infection, postoperative bleeding, cardiopulmonary
events or even death can occur.
These are acceptable risks in view of the fact that chemotherapy in combination
with CRS and HIPEC offers improved curation for this patient category.