hepatic colorectal metastasis treated with Folfiri+Avastin MedDRA version: 14.1 Level: HLT Classification code 10027467 Term: Metastases to specified sites System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: SONOVUE*1FL 8MCG+1SIR 5ML C/BI
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: esafluoruro di zolfo
Current Sponsor code: NA
Other descriptive name: NA
Concentra
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: – Age ? 18 years – Diagnosis of histologically proven inoperable adenocarcinoma of the colon or rectum not suitable for curative-intent resection and candidate to receive CHT+BEV as first line treatment for advanced disease. – Eastern Cooperative Oncology Group-performance status (ECOG-PS) 0-1 The scale is attached below * – At least one liver lesion, measurable according to RECIST criteria and evaluable by CEUS. A CEUS evaluable lesion is defined as: 1. With acoustic window sufficient for adequate US examination of the liver 2. Not previously treated 3. With a diameter of 2 cm or more 4. With a necrosis =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: – Previous chemotherapy for metastatic colorectal cancer (any). Adjuvant therapy is allowed if the chemotherapy treatment free interval is > 6 months – Known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue. – Recent Acute Coronary Syndrome (ACS) or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronarY artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders. - Right-to-left shunts, severe pulmonary hypertension (PAP >90 mmHg), uncontrolled systemic hypertension, and adult respiratory distress syndrome. – Pregnancy or lactation – Inadequate contraception (for both sexes) if of childbearing or procreation potential – Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluation of early response to FOLFIRI+bevacizumab treatment by quantitative analysis of Contrast Enhanced US;Secondary Objective: na;Primary end point(s): to obtain pefusion parameters of contrast enhnaced US;Timepoint(s) of evaluation of this end point: 2-4-8-12-16-20-24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na | — |
Countries
Italy
Contacts
Public ContactCoordinamento Ricerca Clinica
A.O. Spedali Civili di Brescia
Outcome results
None listed