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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT00986518
Eligibility Criteria:
Inclusion Criteria:
* Colon or rectal adenocarcinoma histologically proven;
* Hepatic or lung metastasis (at least one with size \>1cm on CT-scan);
* Not eligible for surgery;
* Prior treatment with fluoropyrimidines, CPT11, oxaliplatine and EGFR antibodies (Cetuximab ou Panitumumab) ± bevacizumab; When tumor has a mutated Kras, prior treatment with EGFR antibodies is not mandatory;
* No local recurrence (on CT-scan, sonogram and/or colonoscopy);
* Karnofsky index \> 70 and PS 0 or 1;
* ASA Score \< 3 ;
* Absence of chronic hepatopathy ;
* Lab test : WBC: neutrophil\> 2.0 109 / l, lymphocytes \> 1.5 109 / l; creatinine \< 1.5 x ULN or clearance ≥ 60 ml/min; AST et ALT\< 5 x ULN, alkaline phosphatases \< 3 x ULN; LDH \< 3 x ULN; negative Coombs test ;
* Signed informed consent.
Exclusion Criteria:
* Peritoneal carcinosis on CT-scan, MRI or PET-scan;
* Contra-indication to MRI;
* Patient with known allergy to iodinated contrast agent, gadolinium or Sulfate Hexafluoron ;
* Presence of metastasis at sites other than lung and liver;
* Documented history of auto-immune disease and/ or progressing disease;
* Infection at whatever site;
* Documented history of allo- or autograft;
* Undernutrition, BMI \< 18;
* History of other cancer \< 5 years (excluding cancer in situ of the cervix and baso-cellular tumor of the skin) or progressing disease;
* Women of child bearing age without contraception , or pregnant or breast feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00986518
Study Brief:
Protocol Section:
NCT00986518