Colorectal cancer and metastatic disease limited to the liver with bad prognosis.
Conditions
Brief summary
Proportion of patients who present an objective radiological response rate at 6 months of treatment. The objective response rate is understood to be the proportion of patients with reduction in tumor size according to RECIST 1.1 criteria.
Detailed description
Overall survival time. Overall survival is understood as the time elapsed from the inclusion of the patient in the study to the date of death from any cause., Progression-free survival time. PFS is understood as the time elapsed from the inclusion of the patient in the study to the date of radiological progression or death. Patients without radiological documentation of progression will be censored on the date of the last control without evidence of progression., Proportion of patients with clinical adverse events, laboratory abnormalities and proportion of patients with discontinuation of treatment due to toxicity or intolerance., Hepatic PFS: time from patient inclusion in the study to liver radiological progression according to RECIST 1.1 criteria., Proportion of patients undergoing R0 surgery for liver metastases.
Interventions
DRUGAvastin 25 mg/ml concentrate for solution for infusion.
DRUGFolinato Cálcico Hikma
DRUG10 mg/ml solución inyectable y para perfusión EFG
DRUGOxaliplatino Kabi 5 mg/ml concentrado para solución para perfusión EFG
DRUGErbitux 5 mg/mL solution for infusion
DRUGIrinotecan Hydrochloride Trihydrate Fair-Med Healthcare 20 mg/ml concentrate for solution for infusion
Sponsors
Grupo Espanol Multidisciplinar En Cancer Digestivo
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who present an objective radiological response rate at 6 months of treatment. The objective response rate is understood to be the proportion of patients with reduction in tumor size according to RECIST 1.1 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time. Overall survival is understood as the time elapsed from the inclusion of the patient in the study to the date of death from any cause., Progression-free survival time. PFS is understood as the time elapsed from the inclusion of the patient in the study to the date of radiological progression or death. Patients without radiological documentation of progression will be censored on the date of the last control without evidence of progression., Proportion of patients with clinical adverse events, laboratory abnormalities and proportion of patients with discontinuation of treatment due to toxicity or intolerance., Hepatic PFS: time from patient inclusion in the study to liver radiological progression according to RECIST 1.1 criteria., Proportion of patients undergoing R0 surgery for liver metastases. | — |
Countries
Spain
Outcome results
None listed