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Trial · NCT07559045

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryComplete Response (CR) Rate at 3 Months After Radiotherapy (Investigator-Assessed)3 months after completion of radiotherapyProportion of patients achieving complete response (CR) per RECIST 1.1, assessed by investigators at 3 months after completion of radiotherapy
Primary1-Year Progression-Free Survival (PFS) Rate1 year after randomizationProportion of patients alive and without disease progression at 1 year after randomization
SecondaryOverall Survival (OS)Up to 3 years after randomizationTime from randomization to death from any cause
SecondaryProgression-Free Survival (PFS)Up to 3 years after randomizationTime from randomization to first documented disease progression or death from any cause, whichever occurs first
SecondaryDuration of Response (DOR)Up to 3 years after randomizationTime from first documentation of objective response (CR/PR) to first documented disease progression or death
SecondaryObjective Response Rate (ORR)Up to 3 years after randomizationProportion of patients achieving CR or partial response (PR) per RECIST 1.1
SecondaryLocal Regional Failure-Free Survival (LRFS)Up to 3 years after randomizationTime from randomization to first local or regional recurrence or death
SecondaryDistant Metastasis-Free Survival (DMFS)Up to 3 years after randomizationTime from randomization to first distant metastasis or death
SecondaryIncidence of Treatment-Emergent Adverse Events (TEAEs)From first study treatment to 30 days after last treatmentIncidence and severity of TEAEs (graded per CTCAE 5.0) during treatment and follow-up
SecondaryEORTC QLQ-OES18 Symptom Score ChangeBaseline, 3 months, 6 months, 12 months after radiotherapy
Change in esophageal cancer-specific symptom score as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Oesophageal 18 (EORTC QLQ-OES18) from baseline to post-treatment follow-ups. The scale ranges from 0 to 100, with higher scores indicating more severe symptoms and worse quality of life.
SecondaryEORTC QLQ-C30 Quality of Life Score ChangeBaseline, 3 months, 6 months, 12 months after radiotherapy.
Change in quality of life score as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) from baseline to post-treatment follow-ups. The scale ranges from 0 to 100, with higher scores indicating better quality of life.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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