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Phase I Trial of CArbonic Anhydrase Inhibition in Combination With Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma

Study acronym: ICAR
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Enrollment target: 30 to 27
    • Study sites: 1 to 2
    v13
  2. Primary endpoint revisedv12 Show 6 more changesShow less
    • Interventions: acetazolamide in combination with platinum and etoposide-based radiochemotherapy (Drug) to acetazolamide in combination with platinum and etoposide-based radiochemotherapy (Drug), acetazolamide in combination with…
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints revised (9)
    • Study description expanded, about 6 words
    • Study arms: 1 to 2
    • Study title shortened, about 1 word
  3. Primary completion date: Nov 30, 2023 to Oct 27, 2026
    • Study completion date: Nov 30, 2024 to Apr 27, 2027
    v11
  4. Primary completion date: Nov 30, 2022 to Nov 30, 2023v10
  5. Primary completion date: Nov 30, 2021 to Nov 30, 2022
    • Study completion date: Nov 30, 2023 to Nov 30, 2024
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. 3 versions Re-verified since Jul 20, 2020, no change to tracked fieldsv6-v8
  2. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jun 30, 2021 to Nov 30, 2021
    • Study completion date: Sep 30, 2023 to Nov 30, 2023
    • Start date changed from estimate of Jun 30, 2019 to Aug 2, 2019
  3. Primary completion date: Sep 30, 2020 to Jun 30, 2021
    • Start date: Sep 30, 2018 to Jun 30, 2019
    • Study completion date: Dec 30, 2022 to Sep 30, 2023
    v4
  4. Start date: Jun 30, 2018 to Sep 30, 2018v3 Show 4 more changesShow less
    • Primary completion date: Jun 30, 2020 to Sep 30, 2020
    • Study completion date: Sep 30, 2022 to Dec 30, 2022
    • Eligibility criteria shortened, about 21 words
    • Secondary endpoints revised (9)
  5. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The investigators propose to study the carbonic anhydrase inhibition (acetazolamide) associated with concomitant radiochemotherapy or radioimmunotherapy in small cell lung cancer due to: 1. The over-expression of carbonic anhydrases in this type of cancer, 2. The Anti-tumor effect in preclinical acetazolamide in various tumor lines including neuroendocrine tumor lines, 3. The observed synergy between irradiation and inhibition of carbonic anhydrases, 4. Potential anti-tumor immune effect caused by decreased extracellular acidity.
Trial Details
NCT Number NCT03467360
Lead Sponsor Centre Antoine Lacassagne
Conditions
(from sponsor)		 Small Cell Lung Cancer
Related terms Small Cell Lung Carcinoma
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov