Phase II Randomised Trial to Assess Progression of Carcinoid Heart Disease in Patients Treated With Lutathera Therapy Compared to Best Supportive Care.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- The rate of progression of moderate carcinoid heart disease (CHD)
研究概览
简要总结
Randomised trial to assess progression of carcinoid heart disease in patients treated with Lutathera therapy compared to best supportive care.
详细描述
This is an open-label, phase II, multicentre, randomised (1:1) clinical trial of an interventional medicinal product. This study will open at 3 centres across the UK. King's College Hospital NHS Foundation Trust will act as the coordinating centre for the study.
In this study, treatment with Lutathera will be compared to treatment with current best supportive care (somatostatin analogues) in patients with inoperable, somatostatin receptor positive, histologically confirmed small bowel NENs and these patients should have stable disease according to RECIST criteria for a period of 6 months prior to study entry.
Patients on the treatment arm will receive four administrations of 7.4 GBq (200 mCi) of Lutathera (and concomitant amino acids will be given with each administration for kidney protection). Patients are scheduled to continue to receive study treatment until any of the following occurs:
- Unacceptable toxicity;
- Progressive disease as determined by RECIST Criteria;
- Inability or unwillingness of the patient to comply with study procedures;
- Patient withdraws consent to participate Patients on the best supportive care arm will receive somatostatin analogue treatment every 4 weeks according to local standard of care practices.
Tumour response in both arms will be assessed after cycles 2 and 4 of 177Lu-Dotatate therapy, or every 16 weeks for patients enrolled under the best supportive care arm, according to RECIST criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Echocardiographic evidence of mild/ moderate carcinoid heart disease.
- •Carcinoid syndrome with Echocardiographic evidence of carcinoid heart disease- to be defined further
- •Elevated urinary 5-HIAA or NYHA class I or II on therapy [not necessarily exceeding label dose of SSA LAR; eg, could be 30mg SMS LAR plus sc SMS for breakthrough]
- •Presence of metastasized or locally advanced, inoperable (curative intent) histologically proven, Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine (GEP-NET) or Lung-NET tumor
- •Ki67 index ≤ 20%
- •Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related activities
- •Confirmed presence of somatostatin receptors on all target lesions documented by CT/MRI scans, within 8 weeks prior to randomization (centrally confirmed), as assessed by the following somatostatin receptor imaging (SRI) modalities: [68Ga]-DOTA-TOC (Somakit-TOC™) PET/CT imaging or [68Ga]-DOTA-TATE PET/CT imaging (NETSPOTTM) or Somatostatin Receptor scintigraphy (SRS) with 111In-pentetreotide (Octreoscan®).
- •Irresectable disease
- •Karnofsky Performance Score (KPS) ≥60.
排除标准
- •Patients with progressive disease by RECIST progressed within 6 months
- •Unable to consent
- •Chemotherapy within 3 months
- •PRRT within 3 years
- •Grade 3 tumours (WHO 2010)
- •Severe or Uncontrolled carcinoid heart disease
- •Renal impairment with eGRF <40 ml/min
- •NYHA class III,IV
研究组 & 干预措施
Lutathera Treatment Arm
• 4x cycles of 7.4 GBq (200mCi) of Lutathera therapy (177Lu-DOTA0-Tyr3-Octreotate) with concomitant amino acids for participants randomised onto the Lutathera therapy arm, every 8 weeks, plus long term somatostatin analogues (SSTA).
干预措施: Lutathera (Drug)
结局指标
主要结局
The rate of progression of moderate carcinoid heart disease (CHD)
时间窗: 5 years
The rate of progression of carcinoid heart disease (CHD) in patients with moderate CHD will be compared across the Lutathera Therapy and Best Supportive Care Arms and will be assessed through RECIST CT/MRI imaging and urinary 5-HIAA levels throughout the duration of the study. The rate of progression will be assessed at each study visit across both arms during the intervention and follow-up phase. If the study treatment is successful in delaying the rate of progression, then the rate of progression in the Lutathera (study intervention) arm is expected to be much slower than in the Best Supportive Care arm.
次要结局
- Progressive disease(5 years)
- Change in quality of life measurements (European Organization for Research and Treatment of Cancer questionnaires, QLQ-C30 and QLQ-GI.NET2)(5 years)
- Change in NYHA heart failure score(5 years)
- Reduction in urinary 5-HIAA levels(5 years)