Trial · NCT05062889
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 | ct-DNA clearance rate after the end of the adjuvant treatment (ERASE-CRC part 1) | 6 months from the enrollment of the last patient in the adjuvant treatment | Percentage of patients, relative to the total of enrolled subjects in the Part 1 of the study with undetectable ct-DNA at the end of adjuvant treatment. |
| Primary | ct-DNA clearance rate after the end of post-adjuvant treatment (ERASE-CRC part 2) | 6 months from the enrollment of the last patient in post-adjuvant treatment | Percentage of patients, relative to the total of enrolled subjects in the Part 2 of the study with undetectable ct-DNA at the end of post-adjuvant treatment. |
| Primary | ct-DNA clearance rate after the end of target-driven adjuvant treatment (ERASE-CRC part 1 target-driven) | 6 months from the enrollment of the last patient in the target-driven adjuvant treatment | Percentage of patients, relative to the total of enrolled subjects in the target-driven part 1 of the study with undetectable ct-DNA at the end of adjuvant treatment. |
| Secondary | Overall Toxicity Rate 1 | 30 days from the last dose of the last patient in adjuvant treatment | Percentage of patients, relative to the total of enrolled subjects in the Part 1 of the study, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during adjuvant treatment and follow-up. |
| Secondary | Toxicity Rate 1 | 30 days from the last dose of the last patient in adjuvant treatment | Percentage of patients, relative to the total of enrolled subjects in the Part 1 of the study, experiencing a specific adverse event of grade ≥ 3, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during adjuvant treatment and follow-up. |
| Secondary | Disease Free Survival 1 (DFS1) | 60 months after the randomization of first patient in adjuvant treatment | Time from randomization of the part 1 of the study to the first documentation of radiological disease relapse or death due to any cause, whichever occurs first. Secondary colorectal cancers are regarded as DFS events, whereas non-colorectal tumors are not. DFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of relapse for patients who are alive, on study and disease free at the time of the analysis. Alive patients having no tumor assessments after randomization will have time to event censored on the date of randomization. |
| Secondary | Overall Survival 1 (OS1) | 60 months after the randomization of first patient in adjuvant treatment | Time from randomization of the Part 1 of the study to the date of death due to any cause. For patients still alive at the time of the analysis, the OS time will be censored on the last date the patients were known to be alive. |
| Secondary | Overall Toxicity Rate 2 | 30 days from the last dose of TRIFLURIDINE/TIPIRACIL | Percentage of patients in the Part 2 of the study, relative to the total of enrolled subjects, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during post-adjuvant treatment and follow-up. |
| Secondary | Toxicity Rate 2 | 30 days from the last dose of TRIFLURIDINE/TIPIRACIL | Percentage of patients, relative to the total of enrolled subjects in the Part 2 of the study, experiencing a specific adverse event of grade 3/4, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during postadjuvant treatment and follow-up. |
| Secondary | Disease Free Survival 2 (DFS2) | 60 months after the randomization of first patient in post-adjuvant treatment | Time from randomization of the part 2 of the study to the first radiological documentation of disease relapse or death due to any cause, whichever occurs first. Secondary colorectal cancers are regarded as DFS events, whereas non-colorectal tumors are not. DFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of relapse for patients who are alive, on study and disease free at the time of the analysis. Alive patients having no tumor assessments after randomization will have time to event censored on the date of randomization. |
| Secondary | Overall Survival 2 (OS2) | 60 months after the randomization of first patient in post-adjuvant treatment | Time from randomization of the part 2 of the study to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive. |
| Secondary | Overall Toxicity Rate TD1 | 30 days from the last dose of the last patient in target-driven adjuvant treatment | Percentage of patients, relative to the total of enrolled subjects in the target-driven part 1 of the study, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during adjuvant treatment and follow-up. |
| Secondary | Toxicity Rate TD1 | 30 days from the last dose of the last patient in target-driven adjuvant treatment | percentage of patients, relative to the total of enrolled subjects in the target-driven part 1 of the study, experiencing a specific adverse event ≥ grade 3, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during adjuvant treatment and follow-up. |
| Secondary | Disease Free Survival TD1 (DFS-TD1) | 60 months after the randomization of first patient in adjuvant treatment | time from enrollment of the target-driven part 1 of the study to the first documentation of disease relapse or death due to any cause, whichever occurs first. Secondary colorectal cancers are regarded as DFS events, whereas non-colorectal tumors are not. DFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of relapse for patients who are alive, on study and disease free at the time of the analysis. Alive patients having no tumor assessments after enrollment will have time to event censored on the date of enrollment. |
| Secondary | Overall survival TD1 (OS-TD1) | 60 months after the randomization of first patient in adjuvant treatment | Time from enrollment of the target-driven part 1 of the study to the date of death due to any cause. For patients still alive at the time of the analysis, the OS time will be censored on the last date the patients were known to be alive. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
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GET https://conductscience.org/api/trials/v1/NCT05062889/registered