IRINOTECAN HYDROCHLORIDE TRIHYDRATE for Colorectal cancer with liver-limited metastases

Inclusion criteria

• {"criterion_text":"- Patients aged ≥ 18 years.\n- Patients with colorectal cancer and exclusive liver metastases with poor prognostic criteria,> 3 lesions and / or size > 5 cm. Patients with the diagnosis of liver metastases with synchronous presentation or with a disease-free interval may be included. If the primary tumor has not been resected, it must be clinically stable. Patients with <3 lesions and/or <5 cm in size may be included if the presentation is synchronous or with a disease-free interval of less than 12 months from the primary tumor surgery. If the primary tumor has not been resected, it must be clinically stable.\n- Measurable disease following RECIST version 1.1 criteria\n- Adequate bone marrow function, according to: a. Hemoglobin ≥ 9.0 g / dl (patients with hemoglobin <9 g / dl can be transfused before inclusion in the study b. Platelet count ≥ 100 x 109 / L c. Absolute neutrophil count (ANC) ≥ 1.5x 109 / L\n- Adequate liver function, based on: a. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN . c. alkaline phosphatase ≤ 5xULN d. Adequate renal function, with creatinine <1.5 mg / dL. BUN < 50 mg / dL and blood urea levels < 18 mmol/L. e. Albumin> 3.0 g / dL\n- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.\n- Patients capable of understanding the information and giving their written informed consent to participate in the study\n- Women and men of childbearing age must commit to abstinence from sexuality or use barrier contraceptive methods during the study and must have a negative pregnancy test."}

Exclusion criteria

• {"criterion_text":"- Extent of the disease> 50% of the liver parenchyma (assessed by CT performed within the month prior to inclusion)\n- Portal thrombosis\n- Severe Hypertension\n- Extrahepatic metastases\n- Patients with liver metastases measuring less than 5 cm or with a total of 3 or fewer lesions. It should be taken into account that patients with <3 lesions and/or <5 cm in size may be included if the presentation is synchronous or with a disease-free interval of less than 12 months from the primary tumor surgery.\n- Prior chemotherapy treatment for metastatic colorectal cancer\n- Clinically significant cardiovascular diseases: cerebrovascular accident / stroke (≤ 6 months before trial inclusion), myocardial infarction (≤ 6 months prior to trial inclusion), unstable angina, uncontrolled hypertension, NYHA grade II or higher congestive heart failure, or severe cardiac arrhythmia.\n- History of malignancy in the last three years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix treated appropriately.\n- Altered coagulation (Quick> 50%)\n- Patients with active infectious processes\n- Patients with any of the contraindications specified in the technical data sheet of the drug under study or with allergies to some of the drugs used\n- Pregnant or lactating patients"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients who present an objective radiological response rate at 6 months of treatment. The objective response rate is understood to be the proportion of patients with reduction in tumor size according to RECIST 1.1 criteria.","definition_or_measurement_approach":"Objective response rate at 6 months measured as the proportion of patients with reduction in tumor size according to RECIST v1.1 criteria."}

Secondary endpoints

• {"endpoint_text":"- Overall survival time. Overall survival is understood as the time elapsed from the inclusion of the patient in the study to the date of death from any cause.","definition_or_measurement_approach":"Overall survival measured as time from inclusion to date of death from any cause."}
• {"endpoint_text":"- Progression-free survival time. PFS is understood as the time elapsed from the inclusion of the patient in the study to the date of radiological progression or death. Patients without radiological documentation of progression will be censored on the date of the last control without evidence of progression.","definition_or_measurement_approach":"PFS measured as time from inclusion to radiological progression or death; censoring at last assessment without progression."}
• {"endpoint_text":"- Proportion of patients with clinical adverse events, laboratory abnormalities and proportion of patients with discontinuation of treatment due to toxicity or intolerance.","definition_or_measurement_approach":"Safety endpoints measured as proportions of patients experiencing clinical adverse events, laboratory abnormalities, and treatment discontinuations due to toxicity or intolerance."}
• {"endpoint_text":"- Hepatic PFS: time from patient inclusion in the study to liver radiological progression according to RECIST 1.1 criteria.","definition_or_measurement_approach":"Hepatic PFS measured as time from inclusion to liver radiological progression per RECIST v1.1."}
• {"endpoint_text":"- Proportion of patients undergoing R0 surgery for liver metastases.","definition_or_measurement_approach":"Measured as proportion of patients who undergo R0 resection of liver metastases."}

Spain

Earliest CTIS Part Ii Submission Date

04-09-2024

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

461

Number Of Sites

9

Number Of Participants

45

Primary sponsor

Full Name

Grupo Espanol Multidisciplinar En Cancer Digestivo

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain