Trial · NCT02934529
Metastatic Colorectal Cancer (RAS-wildtype) After Response to First-line Treatment With FOLFIR Plus Cetuximab
NCT02934529, Phase 3, Completed, Ludwig-Maximilians - University of Munich
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metastatic Colorectal Cancer (RAS-wildtype) After Response to First-line Treatment With FOLFIR Plus Cetuximab. Trials, record NCT02934529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02934529
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metastatic Colorectal Cancer (RAS-wildtype) After Response to First-line Treatment With FOLFIR Plus Cetuximab
- NCT number
- NCT02934529
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 673 participants, actual
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Irinotecan, Folinic Acid, 5-FU, 5-FU, Cetuximab, Bevacizumab, Capecitabine, regorafenib, Irinotecan 125mg, Cetuximab wkly
- First posted
- 2016-10-17
- Last updated
- 2025-04-16
- Other registries' IDs
- eudract:2014-003787-21
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | up to 55 months | overall survival from randomisation to third-line treatment (OS3) under cetuximab rechallenge versus an anti-EGFR-free treatment in patients responding to treatment with cetuximab |
| Secondary | Response Rate | up to 55 months | Response rate ORR1, 2 \& 3 (assessment of ORR 1 and ORR 2 only if the patient was already included in part 1 of the study) |
| Secondary | Progression-free survival | up to 55 months | Progression-free survival PFS1, 2 \& 3 (assessment of PFS 1 and PFS 2 only if the patient was already included in part 1 of the study) |
| Secondary | Overall Survival (first-line treatment) | up to 55 months | Overall survival (OS1) from randomisation to first-line treatment (assessment only if the patient was already included in part 1 of the study) |
| Secondary | Depth of Response | up to 55 months | Investigation of depth of response during first-line treatment and third-line treatment. |
| Secondary | Early tumor shrinkage | up to 55 months | Investigation of early tumour shrinkage during first-line treatment and third-line treatment. |
| Secondary | molecular biomarkers | up to 67 months | Study of molecular biomarkers for prediction of sensitivity and secondary resistance to an anti-EGFR treatment with cetuximab (including tumour biopsies and liquid biopsies from blood samples) |
| Secondary | Biomarker Score | up to 67 months | Prospective validation of a biomarker score (RAS and BRAF) |
| Secondary | tumour marker | up to 55 months | Prospective analysis of tumour marker evolution (CEA and CA 19-9) |
| Secondary | Safety and tolerance as measured by the NCI-CTCAE version 4.03 criteria | up to 55 months | Recording of the safety and tolerance (NCI-CTCAE version 4.03 criteria) of the first-line and third-line treatment |
Source ClinicalTrials.gov
Outcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39903881 | DERIVED |
Source PubMed
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/NCT02934529
GET https://conductscience.org/api/trials/v1/NCT02934529/registered