COLORECTAL NEOPLASTIC DISEASE MedDRA version: 9.1 Level: LLT Classification code 10009973 MedDRA version: 9.1 Level: LLT Classification code 10009974
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Irinotecan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical Form: Solution for i
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Male or female > 18 years ? Histological diagnosis of colon or rectum adenocarcinoma ? Locally advanced or metastatic colorectal carcinoma candidate for chemotherapy and/or target therapy ? Signed informed consent ? Availability to reach the hospital Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Lack of histological diagnosis of colon or rectum adenocarcinoma ? Lack of signed informed consent ? < 18 years ? Any other cancer except melanoma or cervical carcinoma in situ ? Previous chemotherapy treatment ? Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ? Identification of a correlation between the biomarker pattern of expression and the disease progression ? Median duration of response to the therapy ? Progression free survival (PFS) ? Overall survival (OS);Primary end point(s): ? Identification of biomarkers able to predict the therapy responsiveness in patients with colorectal carcinoma;Main Objective: ? Identification of biomarkers able to predict the therapy responsiveness in patients with colorectal carcinoma | — |
Countries
Italy
Outcome results
None listed