RecruitingPhase 2NCT04954820
Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET
A Prospective Randomized Phase II Study Assess the Schema of Retreatment With Lutathera® ([177LU]LU-DOTA-TATE) in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Enrollment
146 participants
Start Date
Oct 18, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit.
Eligibility
Min Age: 18 Years
Inclusion Criteria16
- 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 Criteria18
- 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.
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Interventions
DRUGLutathera
2 additional infusions of Lutathera®
Locations(28)
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NCT04954820
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