Trial · NCT07004413
Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients
NCT07004413, Phase 3, Not yet recruiting, Charite University, Berlin, Germany
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients. Trials, record NCT07004413. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07004413
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients
- NCT number
- NCT07004413
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 267 participants, estimated
- Lead sponsor
- Charite University, Berlin, Germany
- Conditions
- Colorectal Cancer Metastatic
- Interventions
- FOLFIRI+cetuximab, Guardant360 ctDNA assay
- First posted
- 2025-06-04
- Last updated
- 2026-07-29
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) on treatment rate at 12 months | 12 months | Percentage of patients who did not experience disease progression or death, whichever occurs first, while receiving active treatment for 12 months starting from randomization. |
| Secondary | PFS1 to PFSN | up to 24 months | Each PFS from treatment start with FOLFIRI+cetuximab to the first disease progression in the respective treatment period |
| Secondary | Overall survival (OS) | At least 5 years after randomization | Time from randomization to the date of death by any cause |
| Secondary | Objective Response Rate (ORR) | up to 24 months | Radiological objective response as determined by RECIST 1.1 criteria |
| Secondary | Dynamics of the tumor markers CEA and CA19-9 | Up to 24 months | |
| Secondary | Early Tumor Shrinkage (ETS) | 8 weeks | Radiological reduction of tumor volume by 20% at the first re-staging (8 weeks) |
| Secondary | Depth of Response (DpR) | up to 24 months | Maximum relative decrease of radiologically determined tumor mass in percent |
| Secondary | Circulating tumor DNA (ctDNA) as additional prospective biomarker of serum RAS/BRAF wild-type status and predictor early radiological disease progression | Up to 24 months | Prospective validation to use ctDNA based RAS/BRAF mutational analysis in addition to tissue-based RAS/BRAF testing to exclude RAS/BRAF mutant tumors from treatment, definition and validation of a threshold value in ctDNA change predicting progressive disease during treatment pause |
| Secondary | Quality of Life (QoL) | up to 24 months | QoL as assessed with the QoL questionnaire EQ-5D-5L |
| Secondary | Adverse events | up to 24 months | Type, incidence, severity, and causal relationship to IMPs of non-serious adverse events and serious adverse events (severity evaluated according to CTCAE version 5.0) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
Data dates
The day each source was copied for this release.
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 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/NCT07004413
GET https://conductscience.org/api/trials/v1/NCT07004413/registered