Trial · NCT02037048
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence Free Survival (RFS) compared to historical averages | 1 year | Compare the number of study patients who achieved RFS with \>50% remaining viable tumor after response adapted adjuvant chemoradiotherapy to historical data among patients with \>50% viable tumor after induction chemotherapy. A once sided test (p\<=0.05) will be used to describe significance of change. |
| Secondary | Symptomatic response | Up to 5 years | Symptomatic response is defined as improvement in dysphagia by 1 grade from baseline. Level 1 - No dysphagia. Level 2 - Minimal dysphagia, able to swallow liquids and most solid foods, experiencing occasional difficulty. Level 3 - Moderate dysphagia, able to swallow liquids and very soft foods. Level 4 - Severe dysphagia, unable to swallow liquids or solids. Significance of change will be calculated using 95% confidence intervals. |
| Secondary | Endoscopic response | Up to 5 years | Complete response = no residual abnormality (cyT0N0-Stage 0). Partial response = any improvement in the clinically determined T or N stage (without reciprocal deterioration in T or N) when compared to the pretreatment clinical stage as assessed by EGD/EUS. Stable disease = no change in the clinical T or N stage when compared to the pretreatment assessment. Progressive disease = any increase in the T or N stage (irrespective of any reciprocal improvement in the T or N stage) when compared to the pretreatment clinical stage as assessed by EGD/EUS. Endoscopic response will be estimated using exact 95% confidence intervals. |
| Secondary | Pathologic response | Up to 5 years | A positive pathologic response (+PR) will be defined as ≤ 50% residual tumor cells remaining. A negative pathologic response (-PR) will be defined as \>50% residual tumor cells remaining. Pathologic response will be described using exact 95% confidence intervals. |
| Secondary | Complete resection (R0) rate | Up to 5 years | R0 resection is defined as the resection of all gross and microscopic tumor. R0 resections will be estimated using exact 95% confidence intervals. |
| Secondary | Incidence of toxicity | Up to 5 years | Toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The number of toxicities will be estimated using exact 95% confidence intervals. |
| Secondary | RFS within study patients | Time from start of treatment until first recurrence or death from any cause, assessed up to 5 years | RFS will be compared between patients with ≤ 50% and \> 50% viable tumor using the log-rank test. Outcomes will be calculated relative to the start of therapy. Log rank tests will be used to estimate the hazard ratio for RFS for patients with \> 50% viable tumor relative to those with ≤ 50%. If there are a sufficient number of events, multivariable Cox analysis will be done to adjust for other prognostic factors. |
| Secondary | OS | Time from start of treatment until death due to any cause, assessed up to 5 years | OS will be compared between patients with ≤ 50% and \> 50% viable tumor using the log-rank test. Outcomes will be calculated relative to the start of therapy. Log rank tests will be used to estimate the hazard ratio for OS for patients with \> 50% viable tumor relative to those with ≤ 50%. If there are a sufficient number of events, multivariable Cox analysis will be done to adjust for other prognostic factors. |
| Secondary | Rate of Distant Metastatic Control (DMC) | Up to 5 years | Kaplan Meier analysis will be used to estimate distant recurrence |
| Secondary | Loco-regional control (LRC) | Up to 5 years | Kaplan-Meier analysis will be used to estimate local recurrence |
| Other | Change in circulating tumor cells (CTCs) | Baseline to up to 2 months | Change in the amount of CTCs before and after induction chemotherapy will be assessed using either the paired t-test or Wilcoxon signed rank test. |
| Other | Change in Ki-67 expression | Baseline to up to 2 months | Change in Ki-67 expression before and after induction chemotherapy will be assessed using either the paired t-test or Wilcoxon signed rank test. |
| Other | HER2 overexpression | Up to 5 years | HER2 overexpression will be described as frequency counts and percentages. |
| Other | Prognostic effect of CTCs, Ki-67, and HER2 overexpression on pathologic response | Up to 5 years | The prognostic effect of CTCs, KI-67, and HER2 overexpression on pathologic response will be assessed with logistic regression analysis, and the prognostic effect on OS and RFS with Cox proportional hazards analysis. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02037048/registered