Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT03532204
Eligibility Criteria:
Inclusion Criteria:
1. Male or female with age ≥18 years and \<85 years;
2. Patient with histologically proven colorectal cancer;
3. Patient with a curative surgical treatment (R0) of the primary tumor performed;
4. Oligometastatic disease defined as 1 to 3 liver-only metastases (measurable lesion as per RECIST 1.1);
5. Patient unfit for surgery or with unresectable metastases;
6. Maximal diameter of largest metastasis: 30 mm;
7. Patient naïve of chemotherapy in the metastatic setting or after a first-line of chemotherapy for metastatic disease but not having progressed up to 1 year (i.e. slowly progressing disease);
8. WHO status 0-1;
9. Adequate liver function: bilirubin \<3 mg/dL, albumin \>2.5 g/dL;
10. Adequate hematological function: absolute neutrophil count (ANC) \>1.5 x 10⁹/L; platelets \>100 x 10⁹/L, hemoglobin (Hb) \>9 g/dL;
11. Normal PT (\>70%) and PTT except if the patient uses anticoagulants;
12. Liver enzymes \<3 times upper limit of normal;
13. Renal function must be adequate for infusion of iv. contrast agent for CT-scan according to the local policy;
14. Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of study and up to 3 months following completion of therapy;
15. Patient who have received the information sheet, dated and signed the informed consent form;
16. Affiliated to the social security system.
Exclusion Criteria:
1. Healthy liver volume\<700 mL
2. Life expectancy \<3 months;
3. Patient fit for metastasectomy or hepatectomy;
4. Extrahepatic metastases;
5. Cirrhosis with Child Pugh score B or C;
6. More than one line of chemotherapy in the metastatic setting or rapidly progressing disease;
7. Previous local treatment of liver metastases;
8. Treatment with any other investigational agent against cancer;
9. Malignancies other than mCRC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent;
10. Pregnant woman or breast feeding mother;
11. Patient deprived of liberty or placed under the authority of a tutor. Patient with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. Patient unable to understand the purpose of the study (language, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03532204
Study Brief:
Protocol Section:
NCT03532204