Trial · NCT07004413
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 | 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) |
| Other | Translational research | up to 5 years | DNA, mRNA and protein expression derived from FFPE tumor tissue and longitudinal blood samples, role of molecular hyperselection on treatment efficacy, integration of digital pathology using digitalized stained tumor tissue sections |
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
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GET https://conductscience.org/api/trials/v1/NCT07004413/registered