Trial · NCT05062889
Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients
NCT05062889, Phase 2, Suspended, Gruppo Oncologico del Nord-Ovest
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients. Trials, record NCT05062889. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05062889
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients
- NCT number
- NCT05062889
- Status
- Suspended
- Phases
- Phase 2
- Enrollment
- 477 participants, estimated
- Lead sponsor
- Gruppo Oncologico del Nord-Ovest
- Conditions
- Stage II Colon Cancer, Stage III Colon Cancer, HER2-positive Colon Cancer, RAS Wild-type Colon Cancer
- Interventions
5-Fluorouracil continuous infusion FOLFOXIRI schedule, 5-Fluorouracil bolus FOLFOX schedule, 5-Fluorouracil continuous infusion FOLFOX schedule, Oxaliplatin FOLFOX and FOLFOXIRI schedule, Oxaliplatin CAPOX schedule, L-Leucovorin, Capecitabine, Irinotecan, Trifluridine/Tipiracil, Trastuzumab, Tucatinib
- First posted
- 2021-09-30
- Last updated
- 2026-02-03
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05062889
GET https://conductscience.org/api/trials/v1/NCT05062889/registered