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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT04954820
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years,
* Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET),
* Patient previously treated with 4 cycles of Lutathera® (defined as "First PRRT"),
* Disease control after "First PRRT" ≥ 12 months,
* Patient presenting a progression of disease (clinic, biologic and/or radiologic) after a first PRRT,
* Decision of retreatment with Lutathera® (defined as "Second PRRT") validated by RENATEN and/or multidisciplinary tumor board and in the scope of the French reimbursement process,
* ECOG performance status 0-2,
* Life expectancy ≥ 6 months as prognosticated by the physician,
* Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to inclusion : (may be PET imaging (68Ga-based SSTR analogues) or scintigraphy imaging: 111In-pentetreotide or 99mTc-octreotide. At least 90% of lesions must be positive for SSTRi with a significant uptake (\>= liver of surrounding tissue),
* Measurable disease per RECIST 1.1 (Appendix 1), on CT/MRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter, and ≥ 2 radiological tumors lesions in total,
* Adequate bone marrow reserve (Hb \> 8 g/dl, neutrophils ≥ 1500/mm³ and platelets ≥ 80 000/mm³),
* Negative pregnancy test in women of childbearing potential (the β-HCG dosage must be ≤ 4 days before inclusion). Women who have no reproductive potential are postmenopausal women or women who have had permanent sterilization, eg. tubal occlusion, hysterectomy, bilateral salpingectomy),
* Effective contraception in men or women of childbearing or pre-menopausal age and up to a minimum of 6 months following the end of treatment,
* Patient´s signed written informed consent,
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
* Affiliation to the French Social Security System
Exclusion Criteria:
* Patient who did not respond (no CR, PR or SD) to "first PRRT".
* Radiological progression after two cycles of "Second PRRT" according to RECIST version 1.1,
* Grade 4 hematotoxicity and/or nephrotoxicity during the initial PRRT, or unresolved AEs categorized as Grade 2 or higher (as per Common Terminology Criteria for Adverse Events (CTCAE v5.0) from previous PRRT cycles or any other therapy for NET, excluding alopecia and peripheral neuropathy,
* Pancreatic NET,
* NeuroEndocrine Carcinoma,
* Prior external beam radiation therapy to more than 25% of the bone marrow,
* Severe renal (estimated Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) \< 40 mL/min or nephrotic syndrome) or hepatic insufficiency (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2.5 x ULN or ALT/AST \> 5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin \> 2.5 x ULN),
* Serum albumin \< 3.0 g/dL unless prothrombin time is within the normal range,
* Uncontrolled diabetes mellitus as defined by a fasting blood glucose above 2 ULN,
* Uncontrolled decompensated heart failure, myocardial infarction uncontrolled, stroke, pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months,
* Hypertension that cannot be controlled despite medications (≥ 160/95 mmHg despite optimal medical therapy)
* Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease prior to enrolment in the study),
* Pregnancy or breast feeding,
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results,
* Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products,
* Concomitant participation or participation within the last 30 days in another clinical trial,
* History of other solid tumor in 5 years before the inclusion excepted of cancer in situ of the cervix and skin cancer (basal or squamous cell) treated and controlled.
* Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04954820
Study Brief:
Protocol Section:
NCT04954820