untreated patients with advanced colorectal cancer. MedDRA version: 9.1 Level: LLT Classification code 10010035 Term: Colorectal cancer stage IV
Conditions
Sponsors
GOIM GRUPPO ONCOLOGICO MERIDIONALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Locally advanced or metastatic non-resectable colorectal cancer Histologically confirmed adenocarcinoma Presence of at least one measurable lesion Age >= 18 years and 70 at study entry Life expectancy of > 3 months Laboratory data: Neutrophils >= 1.5 x 109/L, platelets >= 100 x 109/L, hemoglobin >= 9 g/dl ALAT and ASAT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Brain metastasis Previous chemotherapy for locally advanced or metastatic colorectal (adjuvant therapy without irinotecan is allowed if recurrence is documented > 6 months after the end of adjuvant treatment) Radiotherapy within 4 weeks prior to study entry Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months Acute or subacute intestinal occlusion or history of the inflammatory bowel disease Patients with peripheral neuropathy (NCI CTC >1) Known drug abuse/alcohol Legal incapacity or limited legal capacity Medical or psychological condition which, in the opinion of the investigator, would not enable the patient to complete the study or knowingly sign the Informed Consent Women who are pregnant or breastfeeding Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (patients with a previous malignancy but with no evidence of disease for > 5 years will be allowed to enter the trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objectively confirmed response rate Time-to- progression;Secondary Objective: Safety of combination Median response duration Overall survival time Post-treatment resectability of lung/liver metastases;Primary end point(s): Objectively confirmed response rate Time-to- progression | — |
Countries
Italy
Outcome results
None listed