Clinical trial · Interventional
Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA), circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that early evaluation could be clinically relevant. Indeed, early tumoral response seems to be correlated to overall survival. Moreover, post-operative morbidity increases with the number of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy regimens when response appears to be insufficient. The aim of the present study is to evaluate, in a prospective cohort of patients treated with systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy as first line treatment for a mCRC, the correlation between early variations of circulating tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3 months objective response as defined in the RECIST 1.1 guideline.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Markers | — | UNRESOLVED | — |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling for free mutant DNA analysis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients Treated for Metastatic Colorectal cancer
- description
- Blood sampling for free mutant DNA analysis for Patients Treated for Metastatic Colorectal cancer
- interventionNames
- Procedure: Blood sampling for free mutant DNA analysis
Primary outcomes (1)
- measure
- Difference from baseline in the number of free mutant DNA in blood
- timeFrame
- 5 weeks
- description
- Variation of free mutant DNA kinetic at week 5 to predict tumor progression at 3 months (Evaluation based on the RECIST 1.1 guideline)
Secondary outcomes (2)
- measure
- Difference from baseline in the number of free mutant DNA in blood
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female, age superior to 18 years. * Histologically confirmed metastatic colorectal adenocarcinoma. * Measurable disease according to the RECIST 1.1 guideline * ECOG performance status \<3. * Disease requiring IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab) every 14 days * No prior chemotherapy for this adenocarcinoma with the exception of adjuvant chemotherapy * Signed and dated informed consent document. Exclusion Criteria: * Medical history of cancer within 5 years * Medical contraindication for a treatment consisted of IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab) * Patient with known psychiatric or substance abuse disorders that could interfere with cooperation with the requirements of the study
References
Publications (1)
- RESULTGrancher A, Beaussire-Trouvay L, Vernon V, Dutherage M, Blondin V, Elie C, Bouhier-Leporrier K, Galais MP, Clabaut T, Bignon AL, Parzy A, Gangloff A, Schwarz L, Leveque E, Sabourin JC, Michel P, Vasseur N, Sefrioui D, Gilibert A, Di Fiore F. ctDNA variations according to treatment intensity in first-line metastatic colorectal cancer. Br J Cancer. 2025 May;132(9):814-821. doi: 10.1038/s41416-025-02971-0. Epub 2025 Mar 15. PMID 40089635