Trial · NCT07900620
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Distant or extraluminal recurrence rate | 3 years | The primary endpoint is 3-year distant or extraluminal recurrence, defined as the occurrence of any distant recurrence or extraluminal local recurrence within 3 years of study enrollment. |
| Secondary | Recurrence-free survival (RFS) | 3 and 5 years | Time from study enrollment to the first occurrence of confirmed recurrence or colorectal cancer-related death. |
| Secondary | Disease-specific survival (DSS) | 3 and 5 years | Time from study enrollment to confirmed colorectal cancer-specific death. Deaths due to other causes will be treated as censoring events. |
| Secondary | Overall survival (OS) | 3 and 5 years | Time from study enrollment to death from any cause. |
| Secondary | Local, distant and overall recurrence | 3 and 5 years | The proportion of participants with confirmed local (intraluminal or extraluminal) recurrence, distant recurrence or overall recurrence during follow-up. Overall recurrence includes both local and distant recurrences. |
| Secondary | Rate of lymph node metastases | 3 and 5 years | The proportion of participants with histologically confirmed lymph node metastases identified in surgical specimens. |
| Secondary | Predictive value of predefined histopathological high-risk factors for histologically confirmed lymph node metastases. | 5 years | The predictive value of predefined histopathological high-risk features, including lymphovascular invasion, tumor budding, poor differentiation, and deep submucosal invasion, for histologically confirmed lymph node metastases will be evaluated. |
| Secondary | Complication and mortality rates (surgical- and non-surgical) | 30 and 90 days | The proportion of participants experiencing complications or death within 30 and 90 days after treatment allocation. Complications will be graded according to the Clavien-Dindo classification |
| Secondary | Long-term complication rates (surgical- and non-surgical) | 5 years | The proportion of participants experiencing treatment-related complications occurring more than 90 days after treatment allocation. |
| Secondary | Number and characteristics of salvage surgeries | 5 years | Number of salvage surgical procedures performed during follow-up, including indications and type of surgery. |
| Secondary | Re-operation rate | 3 and 5 years | The proportion of participants requiring one or more additional surgical procedures following the initial treatment strategy. |
| Secondary | Costs of treatment | 5 years | Direct healthcare costs associated with the assigned treatment strategy, including treatment procedures, hospitalizations, follow-up examinations and management of complications. |
| Secondary | Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | 1, 3 and 5 years | Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores range from 0 to 100. Higher scores indicate better functioning and quality of life for functional and Global Health Status scales, and greater symptom burden for symptom scales. |
| Secondary | Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module (EORTC QLQ-CR29) | 1, 3 and 5 years | Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module (EORTC QLQ-CR29). Scores range from 0 to 100. Higher scores indicate better functioning for functional scales and worse symptoms for symptom scales. |
| Secondary | Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) | 1, 3 and 5 years | Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). EQ-5D-5L index values range from below 0 to 1.0, where 1.0 indicates full health and 0.0 indicates a health state equivalent to death. Higher values 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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