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Trial · NCT04274426

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary
Progression free survival (PFS) defined as the time from randomization to progressive disease (PD) or death, whichever occurs earlier. PD is based on investigator assessment using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Up to 2.5 years. From date of randomization until date of progressive disease (PD) or death, whichever occurs earlier.PD is based on investigator assessment using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
SecondaryOSUp to 2.5 years. From date of randomization until date of death from any cause.Overall survival
SecondaryORRUp to 2.5 years. From date of randomization to date of death death from any cause.Objective response rate
SecondaryEfficacy regarding PFSUp to 2.5 years. From date of randomization to date of death from any cause.Efficacy regarding Progression Free Survival depending on histologic subtype
SecondaryEfficacy regarding OSUp to 2.5 years. From date of randomization to date of death from any cause.Efficacy regarding Overall Survival depending on histologic subtype
SecondaryEfficacy regarding ORRUp to 2.5 years. From date of randomization to date of death from any cause.Efficacy regarding Objective Response Rate depending on histologic subtype
SecondarySerological progressive diseaseUp to 2.5 years. From date of randomization to date of death death from any cause.Time to serological progressive disease according to GCIG criteria
SecondaryTime to first subsequent treatment (TFST)Up to 2.5 years. From date of randomization to date of death from any cause.Time to first subsequent treatment (TFST)
SecondaryTime to second subsequent treatment (TSST)Up to 2.5 years. From date of randomization until date of death from any cause.Time to second subsequent treatment (TSST)
SecondaryPatient-reported outcomesUp to 2.5 years. From date of randomization until date of death from any cause.Quality of Life (EORTC C-30)
SecondaryPatient-reported outcomesUp to 2.5 years. From date of randomization until date of death from any cause.Quality of Life (EORTC OV28)
SecondarySafety and tolerabilityUp to 2.5 years. From date of randomization until date of death from any cause through study completion.Safety and tolerability of the used drugs evaluated by NCI CTCAE v5.0

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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