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Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in Relapse Ovarian Cancer Treatment

Study acronym: CHIPOR
StatusActive, Not Recruiting
PhasePhase 3
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv15
  2. Completion date: May 14, 2025 to May 14, 2027v14
  3. Re-verified, no change to tracked fieldsv13
  4. Primary completion date changed from estimate of Feb 28, 2023 to Jan 8, 2023 Completion date: Feb 28, 2023 to May 14, 2025v12 Show 1 more changeShow less
    • Completion date: Feb 28, 2023 to May 14, 2025
  5. Primary and study completion dates: Dec 26, 2022 to Feb 28, 2023v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Sep 2023 to Dec 26, 2022 Completion date: Sep 2024 to Dec 26, 2022 · Start date: Apr 2011 to Apr 26, 2011v10 Show 2 more changesShow less
    • Completion date: Sep 2024 to Dec 26, 2022
    • Start date: Apr 2011 to Apr 26, 2011
  2. Trial status: Suspended to Active, Not Recruiting Enrollment target: estimated 444 to confirmed 415 · Primary completion date: Sep 2024 to Sep 2023 · Completion date: Apr 2025 to Sep 2024v9 Show 3 more changesShow less
    • Enrollment target: estimated 444 to confirmed 415
    • Primary completion date: Sep 2024 to Sep 2023
    • Completion date: Apr 2025 to Sep 2024
  3. Trial status: Recruiting to Suspended Sponsor's reason: Temporary suspension since March 20th 2020 due to COVID-19 pandemic Site details revised at 33 of 33 sitesv8 Show 1 more changeShow less
    • Site details revised at 33 of 33 sites
  4. Primary completion date: Apr 2020 to Sep 2024 Study sites: 32 to 33 · Completion date: Dec 2020 to Apr 2025 · Interventions: maximal cytoreductive surgery (Procedure) to HIPEC (Drug), Maximal cytoreductive surgery (Procedure) · 3 morev7 Show 6 more changesShow less
    • Study sites: 32 to 33
    • Completion date: Dec 2020 to Apr 2025
    • Interventions: maximal cytoreductive surgery (Procedure) to HIPEC (Drug), Maximal cytoreductive surgery (Procedure)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Publications: 1 to 3
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv6
  6. Primary completion date: Apr 2018 to Apr 2020 Study sites: 23 to 32 · Completion date: Dec 2018 to Dec 2020v5 Show 2 more changesShow less
    • Study sites: 23 to 32
    • Completion date: Dec 2018 to Dec 2020
  7. 2 versions Re-verified since Mar 23, 2015, no change to tracked fieldsv3-v4
  8. Study sites: 20 to 23v2
  1. 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.
UNICANCER
98 trials monitored
See 7 trials at risk
Ovarian Cancer
1,245 trials monitored
See 80 trials at risk
CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required.
Trial Details
NCT Number NCT01376752
Lead Sponsor UNICANCER
Conditions Ovarian Epithelial Cancer Recurrent
Enrollment 415 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov