The IPLA-OVCA Trial, Intra-Peritoneal Local Anaesthetics in Ovarian Cancer
Status:
Recruiting
Trial end date:
2028-08-26
Target enrollment:
Participant gender:
Summary
Surgery and chemotherapy combined constitute first line treatment in women with advanced
ovarian cancer. The aim of surgery apart from staging is cytoreduction, i.e. surgical
resection of tumour. Radical resection of all tumour visible by the naked eye followed by
adjuvant chemotherapy is associated with best chance of prolonged survival. However, because
of tumour dissemination in the peritoneal cavity, radical surgery is often very extensive
with surgery in all quadrants of the abdomen and multi-organ resection with substantial risk
of postoperative severe complications and subsequent delay in administration of adjuvant
chemotherapy. Longer time-interval between surgery to start of adjuvant chemotherapy has been
associated with decrease in survival.
Surgery presents opportunities not only for eradicating tumours but, paradoxically, also for
proliferation and invasion of residual cancer cells. It increases the shedding of malignant
cells into the blood and lymphatic circulations, inhibits their apoptosis and potentiates
their invasion capacity. Additionally, the immune system, the inflammatory system and the
neuroendocrine system react to surgery with important changes, which have been proven to
promote progression of cancer. Several anaesthesia-related factors play an important role in
perioperative tumorigenesis such as inhalational anaesthetics, opiate analgesics, local
anaesthetics and regional anaesthesia, all of which may impact short-term morbidity and
long-term mortality. A previous randomized placebo-controlled pilot study suggests that women
who receive local anesthetics intraperitoneally preoperatively have a significantly decreased
time-interval to initiation of adjuvant chemotherapy.
In a prospective, randomised, multi-centre study, we plan to further assess if
intraperitoneal local anaesthetics administered perioperatively during 72 h leads to early
start of chemotherapy compared to placebo in patients undergoing cytoreductive surgery for
FIGO stage III-IV ovarian cancer.
Phase:
Phase 3
Details
Lead Sponsor:
Karolinska Institutet
Collaborators:
Karolinska University Hospital Skane University Hospital