VINORELBINE for Metastatic colorectal cancer

Inclusion criteria

• {"criterion_text":"- histologically proven diagnosis of CRC;"}
• {"criterion_text":"- measurable metastatic disease according to RECIST 1.1;"}
• {"criterion_text":"- availability of histological specimens;"}
• {"criterion_text":"- no evidence of brain or meningeal disease. Treated and clinically stable brain metastases are permitted;"}
• {"criterion_text":"- age ≥ 18 years;"}
• {"criterion_text":"- ECOG performance status = 0-2;"}
• {"criterion_text":"- life expectancy > 3 months;"}
• {"criterion_text":"- patients must have received all standard treatments indicated for metastatic disease (chemotherapy and/or targeted or immunological therapy) and have relapsed or progressed compared to a previous therapy."}
• {"criterion_text":"- if female of childbearing age, have a negative pregnancy test performed no more than 7 days before the start of study treatment;"}
• {"criterion_text":"- If female of childbearing potential or male, agree to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double barrier method) based on investigators judgment; Childbearing patients must use two methods of contraception;"}
• {"criterion_text":"- Adequate bone marrow, liver, and kidney function assessed within 14 days prior to the start of study treatment;"}
• {"criterion_text":"- Patients able to understand the Italian language and to adhere to the study by signing, personally or by means of a designated witness, the informed consent (to trial and to data processing) prior to any study-specific procedures;"}
• {"criterion_text":"- Patients must be fit for treatment and follow-up."}
• {"criterion_text":"- Investigators must ensure that enrolled patients in this trial will be available to provide complete documentation of treatment, toxicity, response assessment, and FU."}

Exclusion criteria

• {"criterion_text":"- Patients with a history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in situ cervical cancer, prostate cancer with stable PSA for ≥ 3 years, or other curatively treated solid tumors with no evidence of disease for ≥ 5 years;"}
• {"criterion_text":"- Pregnant or breastfeeding women."}
• {"criterion_text":"- Patients receiving concomitant treatment with other anticancer therapies;"}
• {"criterion_text":"- Patients with active or uncontrolled infections, or serious illnesses or medical conditions that would not allow that patient to be managed according to the protocol;"}
• {"criterion_text":"- Patients with untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction in the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) are not eligible;"}
• {"criterion_text":"- Other concomitant investigational drugs."}
• {"criterion_text":"- Known intolerance to the study drug or any of the excipients."}
• {"criterion_text":"- Any pre-existing or current medical or other condition that in the opinion of the investigator(s) would preclude the participant from participating in this study"}

Primary endpoints

• {"endpoint_text":"- ORR is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria. The determination of clinical response will be based on investigator-reported measurements. Responses will be evaluated with a chest and abdominal computed tomography (CT) scan every 8 weeks. Patients who do not have an on-study assessment will be included in the analysis as non-responders.","definition_or_measurement_approach":"ORR per RECIST 1.1; investigator-reported measurements; chest and abdominal CT scan every 8 weeks; patients without on-study assessment included as non-responders."}

Secondary endpoints

• {"endpoint_text":"- Progression-free survival (PFS).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival (OS).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Toxicity rate.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quality of Life (QoL) is","definition_or_measurement_approach":""}

Italy

Earliest CTIS Part Ii Submission Date

15-01-2025

Latest Decision Or Authorization Date

09-05-2025

Processing Time Days

114

Number Of Sites

1

Number Of Participants

25

Primary sponsor

Full Name

I.F.O. Istituti Fisioterapici Ospitalieri

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy