Phase 1 Study of Perioperative Peptide Receptor Radionuclide Therapy (PRRT) in Metastatic, WHO Grade 1 or 2, SSTR Positive, Gastroenteropancreatic Neuroendocrine Tumors Who Are Candidates for Cytoreductive Surgery
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Measure Complication free Surgery
研究概览
简要总结
The purpose of this study is to learn about the feasibility and safety of using Peptide Receptor Radionuclide Therapy (PRRT) before and after surgical removal of a tumor. PRRT treatment is based on the administration of a radioactive product, 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) and its use before and after surgery is thought to increase the overall survival benefit for patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors GEP-NETs.
详细描述
Primary Objective(s)
- To assess feasibility and safety of combination of perioperative 177Lu Dotatate and cytoreductive surgery in metastatic GEP NETs Secondary Objective(s)
- To assess response rate (RR) after 2 cycles 177Lu Dotatate
- To assess recurrence free survival (RFS) of the overall treatment strategy
- To assess overall survival (OS) of the overall treatment strategy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only.
- •WHO Grade 1 or 2, Ki 67 ≤ 20% (to be confirmed at Stanford)
- •Must be a candidate for cytoreductive surgery with the goal of R1 resection as determined by a multidisciplinary tumor board discussion
- •Measurable disease as determined by RECIST v1.1
- •Confirmed presence of somatostatin receptors on all target lesions as determined by 68Ga DOTA TATE PET scan
- •Patients ≥ 18 years of age.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
- •Appropriate hematologic, liver and kidney function
- •Patients on octreotide long-acting release (LAR) at a fixed dose of 20 mg or 30 mg at 3 to 4 weeks intervals for at least 12 weeks prior to enrollment in the study
排除标准
- •Prior 177Lu Dotatate treatment
- •Any surgery or radiofrequency ablation within 12 weeks prior to enrollment in the study; or prior radioembolization; chemoembolization; or external beam radiation therapy (EBRT) to > 25% of bone marrow, at any time
- •Any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4 weeks prior to enrollment in the study
- •Known brain metastases
- •Known bone or peritoneal metastases
研究组 & 干预措施
Lutathera
2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT
干预措施: PET/CT (Procedure)
Lutathera
2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT
干预措施: Computed Tomography (CT) (Procedure)
Lutathera
2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
Lutathera
2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT
干预措施: Lutathera (Drug)
Lutathera
2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT
干预措施: Gallium 68 Dotatate (Drug)
结局指标
主要结局
Measure Complication free Surgery
时间窗: 6 months
The feasibility of perioperative 177Lu Dotatate as part of the therapeutic regimen to treat metastatic neuroendocrine tumors (NETs) will be assessed on the basis of number and proportion of participants who undergo 2 cycles of complication free 177Lu Dotatate therapy followed by cytoreductive surgery without complications, expressed as a number without dispersion. Complications are defined as follows. * Radiation fibrosis * Hepatic fibrosis by histologic diagnosis * Hepatic insufficiency * Bowel anastamotic leak (if bowel surgery) * Distal pancreatic leak (if pancreas surgery)
次要结局
- Recurrence free Survival (RFS)(1 year)
- Response Rate (RR)(16 weeks)
- Overall Survival (OS)(1 year)