2024-511001-28-00招募中2 期
A PROSPECTIVE RANDOMIZED PHASE II STUDY TO ASSESS THE SCHEMAS OF RETREATMENT WITH LUTATHERA® ([177LU]LU-DOTA-TATE) IN PATIENTS WITH NEW PROGRESSION OF INTESTINAL WELL-DIFFERENTIATED NEUROENDOCRINE TUMOR
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 27
- 主要终点
- Disease Control Rate (DCR) at 6 months from randomization (defined as Complete Response, Partial Response and Stable Disease from RECIST v1.1 with an evaluation every 2 months.
研究概览
简要总结
To evaluate the efficacy of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance during 6 months in patients already retreated with two cycles.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •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 7 months for female patients and 4 months for male patients 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.
- •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 or surrounding tissue),
排除标准
- •Patient who did not respond (no CR, PR or SD) to “first PRRT”.
- •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.
- •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 Cockcroft Gault method < 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,
结局指标
主要结局
Disease Control Rate (DCR) at 6 months from randomization (defined as Complete Response, Partial Response and Stable Disease from RECIST v1.1 with an evaluation every 2 months.
Disease Control Rate (DCR) at 6 months from randomization (defined as Complete Response, Partial Response and Stable Disease from RECIST v1.1 with an evaluation every 2 months.
次要结局
- The Safety according to NCI-CTCAE v5.0
- rPFS defined as the time from randomization until documented disease progression on radiological tumor assessment (as evaluated by an independent central review by radiologists blindly of the treatment assignments according to RECIST v1.1) or death from any cause, whichever occurs first.
- PFS defined as the time from randomization until documented disease progression on radiological tumor assessment (as evaluated by an independent central review by radiologists blindly of the treatment assignments according to RECIST v1.1) or clinical progression or death from any cause, whichever occurs first
- OS defined as the time from randomization until death from any cause.
- QoL assessed by EORTC QLQ-C30 and EORTC GI.NET21 questionnaires
研究者
Dr Emmanuel DESHAYES
Scientific
Institut Regional Du Cancer De Montpellier
研究点 (27)
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