Trial · NCT07900061
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival (DFS) | up to 5 years | Time from randomization to the first occurrence of locoregional recurrence, distant metastasis, new invasive primary colorectal carcinoma or death from any cause, whichever occurs first. |
| Secondary | Complete Response (CR) rate | Up to 6 months | The complete response (CR) rate is defined as the proportion of subjects achieving a complete response including clinical complete response accepting watch and wait strategy and pathological complete response who underwent the surgery. |
| Secondary | Overall Survival (OS) | Up to 8 years | Overall survival (OS) is defined as the time interval from randomization to death from any cause. |
| Secondary | Organ Preservation Rate (OPR) | Up to 5 years | Organ preservation rate (OPR) is defined as the proportion of participants with successful organ preservation at the pre-specified time point from randomization. Organ preservation is regarded as failure if any of the following occurs: 1) performance of definitive total mesorectal excision (TME); 2) development of unresectable locoregional tumor regrowth or recurrence; 3) creation of permanent stoma. Local excision is not considered definitive radical resection. |
| Secondary | Locoregional Control Rate (LCR) | Up to 5 years | Locoregional control rate (LCR) is defined as the proportion of subjects without locoregional failure from randomization up to the prespecified time point. Locoregional failure is defined as the first documented occurrence of primary rectal tumor regrowth or pelvic regional nodal recurrence. Isolated distant metastasis alone shall not be regarded as locoregional failure. |
| Secondary | Locoregional Recurrence Free Survival (LRFS) | Up to 5 years | Locoregional recurrence free survival (LRFS) is defined as the time interval from randomization to the first documented locoregional failure. Locoregional failure is defined as the first documented occurrence of primary rectal tumor regrowth or pelvic regional nodal recurrence. |
| Secondary | Distant Metastasis-Free Survival (DMFS) | Up to 5 years | Distant metastasis free survival (DMFS) is defined as the time interval from randomization to the first documented distant metastatic event. Distant metastatic event is defined as the first documented distant metastasis outside the pelvis. |
| Secondary | Adverse Event (AE) | Up to 5 years | Any untoward medical occurrence temporally associated with study treatment, whether or not related to the study intervention. The incidence rates of adverse events will be calculated and compared between the two treatment groups. |
| Secondary | Quality of life (QoL) assessment via EORTC QLQ-C30 | Up to 5 years | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. This is a validated patient-reported questionnaire for cancer patients. The scale score ranges from 0 to 100. Higher scores indicate better global health status and quality of life. |
| Secondary | Quality of life (QoL) assessment via EORTC QLQ-CR29. | Up to 5 years | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29). The scale score ranges from 0 to 100. Higher scores indicate better body image but more severe blood and mucus in stool and more severe stoma care problems. |
| Secondary | Quality of life (QoL) assessment via Wexner Score | Up to 5 years | Cleveland Clinic Florida Fecal Incontinence Score (Wexner Score). A validated patient-reported scale to assess the severity of fecal incontinence. The total score ranges from 0 to 20. Higher scores indicate more severe fecal incontinence. |
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/NCT07900061/registered