RECTAL CARCINOMA WITH RESECTABLE METASTASES AT DIAGNOSIS MedDRA version: 9.1 Level: LLT Classification code 10055097 Term: Rectal cancer metastatic
Conditions
Interventions
Trade Name: FLUOROURACILE ICN
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Fluorouracil
Concentration unit: % percent
Concentration type: equal
Concentration number: 5-
Trade Name:
Sponsors
ISTITUTO ONCOLOGICO VENETO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: every age (patients >=70 years old will undergo multidimensional geriatric assessment), histological diagnosis of middle-low rectal carcinoma, measurable synchronous metastases at the diagnosis according to WHO criteria, chemonaive patients, female potential fertile patients and sexually active males only under active contraception during and at least one year after completing treatment, ECOG PS=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: active second malignancy (with exception of skin and in-situ cervical tumors), other malignancies whitin the last 5 years except cured basal cell carcinoma of the skin and carcinoma in-situ of the uterin cervix, ceongestive hearth failure grade 2, myocardial infarction in the last year, unstable angina, uncontrolled hugh risk hypertension or arhythmias, hystory of significant history of significant neurological or psychiatric disorders including dementia or seizures, serious uncontrolled active infections or any other serious uncontrolled concomitant illness, ictus within the last 6 months, interstitial pulmonary disease; peripheral neuropathy >= grade 1, chronic enteric diseases (Crohn disease, ulcerous colitis), unresolved diarrhoea and bowel obstruction; documented cerebral metastasis, anticoagulant therapy or FANS ongoing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: response rate 1. primitive tumor downstagining 2. sphincter-saving 3. synchronous metasteses response;Secondary Objective: resectability rate, toxicity rate, time to progression computed from the enrolment to the date of local or distant relapse, overall survival computed from the enrolment to the date of the death for any-cause, quality of life +/- multidimensional geriatric assessment improvement in symptomatic cases, TRG correlation between metastases and primitive lesion, TRG correlation with DFS and OS;Primary end point(s): response rate 1. primitive tumor downstagining 2. sphincter-saving 3. synchronous metasteses response | — |
Countries
Italy
Outcome results
None listed