ELDERLY PATIENTS WITH METASTATIC COLORECTAL CANCER MedDRA version: 6.1 Level: HLT Classification code 10010040
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fluorouracil, combinations
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form:
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: CYTOLOGICALLY OR HISTOLOGICALLY DIAGNOSED METASTATIC COLORECTAL CANCER BIDEMENSIONALLY EVALUABLE DISEASE METASTATIC DISEASE ECOG LESS OR EQUAL TO 2 AGE 70 OR OLDER NO PREVIOUS CHEMOTHERAPY TREATMENT FOR METASTATIC DISEASE WRITTEN INFORMED CONSENT GOOD HEMATOLOGICAL, LIVER AND RENAL FUNCTIONS Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: PREVIOUS DIAGNOSIS OF TUMOUR OTHER THAN BASAL SKIN CARCINOMA OR IN SITU CANCER OF THE UTERINE CERVIX METAL ILLNESS SYMPTOMATIC CNS METASTASES INFLAMMATORY BOWEL DISEASE SERIOUS ORGAN FAILURE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ACTIVITY OF CHEMOTHERAPY;Secondary Objective: TOXICITY OF CHEMOTHERAPY;Primary end point(s): RESPONSE RATE | — |
Countries
Italy
Outcome results
None listed