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

Study acronym: IPLA-OVCA
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years 8 months later Jan 10, 2024 → Sep 28, 2028
See other at-risk trials from Karolinska Institutet

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jan 10, 2024 to Sep 28, 2028 Show 5 more changesShow less
    • Study completion pushed from Aug 26, 2028 to Sep 28, 2029
    • Start date: Aug 26, 2020 to Aug 27, 2020
    • Eligibility criteria expanded, about 8 words
    • Study description revised
    • Publications: details revised at 5 of 5 entries
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 26, 2023 to Jan 10, 2024
    • Site details revised
    v5
  3. Minor Primary completion date: Aug 26, 2023 to Dec 26, 2023v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 12 more changesShow less
    • Primary completion date: Dec 2022 to Aug 26, 2023
    • Start date changed from estimate of Jan 2020 to Aug 26, 2020
    • Primary endpoint revised
    • Enrollment target: 200 to 220
    • Study completion date: Dec 2025 to Aug 26, 2028
    • Secondary endpoints: 2 to 4
    • Study description expanded, about 219 words
    • Site details revised
    • Collaborator revised
    • Publications: 4 to 5
    • Eligibility criteria expanded, about 1 word
    • Study title expanded, about 3 words
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04065009
Lead Sponsor Karolinska Institutet
Collaborators: Skane University Hospital
Conditions
(from sponsor)
Advanced Ovarian Cancer
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov