Status:
ACTIVE_NOT_RECRUITING
The IPLA-OVCA Trial, Intra-Peritoneal Local Anaesthetics in Ovarian Cancer
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Skane University Hospital
Conditions:
Advanced Ovarian Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE3
Brief 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. Radi...
Detailed Description
Epithelial ovarian cancer (EOC) is the common term for cancer that originate from the surface of the ovary, lining of the fallopian tube and the peritoneum. There are different histopathological subty...
Eligibility Criteria
Inclusion
- ASA I-III
- Scheduled for upfront cytoreductive surgery for presumed stage III or IV epithelial ovarian cancer
- Signed written informed consent
Exclusion
- Contraindication to epidural anesthesia
- Allergy to any component drugs used during epidural or intraperitoneal anesthesia (Ropivacaine, Sufentanil)
- Uncontrolled renal, liver, heart failure or ischemic heart disease
- Speech, language or cognitive difficulties
- Women in whom cytoreductive surgery is not attempted at time of upfront laparotomy due to extent of disease
Key Trial Info
Start Date :
August 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 26 2028
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04065009
Start Date
August 26 2020
End Date
August 26 2028
Last Update
January 11 2024
Active Locations (1)
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1
Karolinska Hospital, Solna
Stockholm, Sweden, 17176