Clinical trial · Interventional
Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer
Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer: a Preliminary Study
NCT02849106CI-TRIAL-00032371CULTURE3DcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture 3D (chemogram obtaining) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy to obtain a chemogram | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- biopsy to obtain a chemogram
- interventionNames
- Procedure: biopsy to obtain a chemogram
Primary outcomes (1)
- measure
- Number of interpretable chemogram
- timeFrame
- through study completion, an average of 1 year
- description
- In ex vivo 3D culture from tumor biopsies, number of interpretable chemogram.
Secondary outcomes (3)
- measure
- Correlation between chemogram results obtained by 3D culture and RECIST 1.1 response assessement.
- timeFrame
- through study completion, an average of 1 year
- description
- Number of chemogram showing the same response to treatment than patient RECIST 1.1 measured response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 years old or more 2. Colorectal cancer with synchronous or metachronous metastases 3. Metastasis and/or primitive tumor (in case of synchronous metastases) accessible to biopsy 4. Measurable metastatic disease (echography, CT and/or MRI, PET-FDG) 5. Indication for treatment with a combination including FOLFOX/FOLFIRI associated to an anti VEGF drug (Avastin) 6. No adjuvant chemotherapy for the primitive colorectal cancer and no line of chemotherapy for metastatic disease during the year prior to inclusion. 7. Life expectancy \> 3 months (ECOG 0-1-2). 8. Informed and signed consent by the patient. Exclusion Criteria: 1. Elevation of Carcinoembryonic antigen (CEA) without measurable metastatic disease 2. Medical contraindication to chemotherapy or biotherapy as FOLFOX/FOLFIRI or Avastin. 3. Treatment with FOLFOX/FOLFIRI and biotherapy anti-EGFR (epidermal growth factor receptor)(Erbitux) planned 4. Patient already enrolled in an other clinical trial with another first line of chemotherapy. 5. Pregnant women, breastfeeding or of childbearing age not taking contraceptive 6. Persons deprived of liberty. 7. Subject unable to make follow up schedule
References
Publications (0)
Data not yet available
No reference posted for this study.