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Trial · NCT07895745

Registered outcomes14

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

ListOutcomeTime frameDescription
PrimaryLocal Control (LC)From randomization until local failure or last follow-up (up to 2 years)Local control (LC), defined as the time from randomization to the date of local failure, after comprehensive clinical examination and radiographic evaluation.
SecondaryLocoregional Failure (LRF)2 Years
SecondaryDistant Metastasis (DM)2 Years
SecondaryLaryngectomy free survival (LFS)2 Years
SecondaryDisease free survival (DFS)2 Years
SecondaryOverall survival (OS)2 YearsOverall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause.
SecondaryPhysician-assessed toxicities2 YearsNational Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.6, where higher grades indicate greater severity of toxicity.
SecondaryPatient-reported toxicities2 YearsPatient Reported Outcomes - Common Terminology Criteria of Adverse Events (PRO CTCAE) V.1, where higher scores indicate greater symptom burden and worse patient-reported toxicity.
SecondaryQuality of life (QOL) (UW-QOL)2 yearsHead and Neck Cancer Specific QOL \[University of Washington Quality of Life Questionnaire (UW-QOL)\], where higher scores indicate a better quality of life.
SecondaryQuality of life (QOL): Voice Handicap Index (VHI)2 Years
Voice Handicap Index (VHI): a patient-reported questionnaire that assesses the functional, physical, and emotional impact of voice disorders, where higher scores indicate greater voice-related handicap.
SecondaryQuality of life (QOL): Swallowing-related quality of life [M.D. Anderson Dysphagia Inventory (MDADI)]2 Years
Swallowing-related quality of life \[M.D. Anderson Dysphagia Inventory (MDADI)\]: a patient-reported questionnaire assessing the impact of dysphagia on quality of life. Higher scores indicate better swallowing-related quality of life.
SecondaryFinancial Toxicity2 YearsFinancial Index of Toxicity (FIT)\]: assesses the financial burden and impact of cancer treatment on patients. Higher scores indicate greater financial toxicity
SecondaryHealth Economics (EQ-5D-5L)2 YearsCost-utility analysis using health utilization costs and health utility instruments (EQ-5D-5L), including lost productivity. Higher scores indicate better health-related quality of life.
SecondaryHealth Economics (HNC-8D)2 YearsCost-utility analysis using health utilization costs and health utility instruments (HNC-8D), including lost productivity. Higher scores indicate better health status.

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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