Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The IPLA-OVCA Trial, Intra-Peritoneal Local Anaesthetics in Ovarian Cancer (IPLA-OVCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065009
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
Skane University Hospital
Information provided by (Responsible Party):
Sahar Salehi, Karolinska Institutet

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. 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.


Condition or disease Intervention/treatment Phase
Advanced Ovarian Cancer Drug: Ropivacaine Drug: Saline Solution Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, double blind, prospective, multicenter
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Study drugs are blinded and administered perioperatively. Fully blinded for all (participants, assessors etc)
Primary Purpose: Other
Official Title: A Randomized Double Blind, Multicenter Trial to Assess Time-interval Between Cytoreductive Surgery and Adjuvant Chemotherapy After Administration of Local Anesthetic Intraperitoneally/Perioperatively in Advanced Epithelial Ovarian Cancer
Actual Study Start Date : August 26, 2020
Estimated Primary Completion Date : August 26, 2023
Estimated Study Completion Date : August 26, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Placebo Comparator: Placebo
Normal saline administered intraperitoneally at defined times during upfront surgery and intermittently postoperatively for 72 hours
Drug: Saline Solution
Placebo will be administered intraperitoneally
Other Name: Normal saline

Experimental: Experimental
Local anesthetic (ropivacaine) administered intraperitoneally at defined times during upfront surgery and intermittently postoperatively for 72 hours
Drug: Ropivacaine
Experimental drug will be administered intraperitoneally
Other Name: Narop




Primary Outcome Measures :
  1. Time-interval from upfront surgery to adjuvant chemotherapy [ Time Frame: Number of days to start of adjuvant chemotherapy (0 - 60 days) ]
    Days from surgery to first infusion of adjuvant chemotherapy


Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days postoperatively ]
    Assessed according to the Clavien-Dindo Nomenclature

  2. Overall survival [ Time Frame: 3 and 5 years after surgery ]
    Death of any reason

  3. Postoperative quality of recovery [ Time Frame: Perioperatively ]
    As measured by validated instruments

  4. Postoperative morbidity [ Time Frame: Perioperatively ]
    As measured by validated instruments



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III
  • Scheduled for upfront cytoreductive surgery for presumed stage III or IV epithelial ovarian cancer
  • Signed written informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065009


Contacts
Layout table for location contacts
Contact: Sahar Salehi, MD, PhD 08-51770000 sahar.salehi@sll.se
Contact: Emma Hasselgren, MD 08-51770000 emma.hasselgren@sll.se

Locations
Layout table for location information
Sweden
Karolinska Hospital, Solna Recruiting
Stockholm, Sweden, 17176
Contact: Katja Tobin Klinisk prövningsledare/Clinical Research Manager    +46 8 517 745 15    katja.tobin@sll.se   
Contact: Katja Wiklund Clinical Research Manager/Quality coordinator    +46 8 517 725 84    katja.wiklund@sll.se   
Sponsors and Collaborators
Karolinska Institutet
Skane University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Sahar Salehi, MD, PhD Karolinska Institute and Karolinska University Hospital
Publications:
Layout table for additonal information
Responsible Party: Sahar Salehi, Senior Consultant, Assistant Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04065009    
Other Study ID Numbers: 20190729
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All study data will be retained at site of patient recruitment. Primary investigator and statistician will only have access to coded patient identity

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sahar Salehi, Karolinska Institutet:
Local Anesthesia
Time-interval from surgery to adjuvant chemotherapy
advanced ovarian cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents