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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT02465112
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent,
* Age ≥ 18 years,
* Patients with well differenciated digestive neuroendocrine tumors and liver metastases, for whom a complete surgical resection of liver metastases and of the primary tumor was performed, in 1 or 2 times,
* Immunohistochemical confirmation of neuroendocrine tumors with WHO 2010 grading specification and Ki67 determined of the surgical specimen,
* ECOG Performance Status (PS) 0-1,
* Adequate hematological status: Platelets \>100000/mm3, Hemoglobin \>10g/dL,
* Adequate Clearance Creatinine \>60 mL/min,
* Adequate liver function: Total Serum Bilirubin \<1.5x upper limit of normal (ULN), transaminases \<3 x ULN,
* Grade of In111-Pentetreotide uptake ≥ 2 (scored according to the Krenning et al scale.: more intense than physiological liver uptake),
* Treatment started within 14 weeks after surgical resection,
* Men and women are required to use adequate birth control measures during the course of the study and for a period of 12 months after the last administration of study drug. Female patients with childbearing potential must have a negative serum pregnant test (β-HCG) within 7 days before starting study treatment,
* Life expectancy \>6 months
* Registration with the National Health Care System (CMU included for France)
Exclusion Criteria:
* History of previous or second cancer or progressive cancer occurring within 5 years prior to inclusion, except for basal cell or squamous cell carcinoma,
* Patients with known sensibility or hypersensibility to In111- Pentetreotide or any component of the treatment drug,
* Pregnant or breast-feeding women without adequate birth control measures,
* Patient with known medical history of psychological or psychiatric disorders that may affect patient participation in study due to lack of cooperation or loss of autonomy preventing hospitalization and initiation of study treatment (in good radiation protection conditions),
* Treatment with any investigational drug within 28 days prior to study entry,
* Patient protected by law (tutelage or guardianship).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02465112
Study Brief:
Protocol Section:
NCT02465112