Combination External Radiation and 177Lu-DOTATATE for Large Gastrointestinal Neuroendocrine Tumors: A Single Arm Pilot Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Incidence of Acute Grade 3+ Non-Hematologic Adverse Events
研究概览
简要总结
This phase I trial tests the safety and effectiveness of stereotactic body radiation therapy (SBRT) followed by 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) in treating patients with large well-differentiated grade 1-2 digestive system neuroendocrine tumors that cannot be removed by surgery (unresectable). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body. The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. 177Lu-DOTATATE is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. 177Lu-DOTATATE builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Giving PRRT after SBRT may reduce the chances of the disease returning or getting worse, compared to the standard treatment of PRRT alone.
详细描述
PRIMARY OBJECTIVE:
I. To determine the rate of acute grade 3+ non-hematologic toxicity of PRRT after external radiation compared to historical control of PRRT alone.
SECONDARY OBJECTIVES:
I. To determine the rate of acute grade 2+ toxicity compared to historical control of PRRT alone.
II. To determine response rate of both large and small lesions at 3 months following treatment.
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
- •Male or female
- •Age ≥ 18 years
- •Patient must be able to provide study specific informed consent
- •Pathologically confirmed neuroendocrine tumor fulfilling all of the following criteria
- •Well-differentiated, grade 1-2
- •Unresectable (prior resection is allowable), verified by tumor board or surgical oncology (surg onc)
- •Progression after one or two prior lines of systemic therapy
- •Somatostatin-receptor positive disease as determined by positive radiotracer-labeled DOTATATE PET/CT scan (modified Krenning score 3+)
- •One or more large lesions measuring 3 or more cm on contrast-enhanced CT or MRI
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Estimated glomerular filtration rate (GFR) > 30 mL/min (within 90 days prior to study registration)
- •Total bilirubin ≤ 3 x upper limit of normal (within 90 days prior to study registration)
- •Albumin > 30 g/L (within 90 days prior to study registration)
- •White blood cell (WBC) ≥ 2,000 cells/mm^3 (within 90 days prior to study registration)
- •Platelets ≥ 70000 cells/mm^3 (within 90 days prior to study registration)
- •Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 8.0 g/dl is acceptable.) (within 90 days prior to study registration)
排除标准
- •Any prior radiation therapy including prior PRRT, external radiation, or Yttrium-90 radioembolization to the same site/region
- •Contraindications to radiation therapy including inflammatory bowel disease, systemic sclerosis, etc.
- •Brain metastases or any metastases extending into the spinal canal
- •Unable to obtain confirmation of payment coverage for any planned radiation treatment
研究组 & 干预措施
Treatment (SBRT, 177Lu-DOTATATE)
Patients undergo SBRT over 5 fractions in the absence of disease progression or unacceptable toxicity. Starting 4-10 weeks after completion of SBRT, patients receive SOC 177Lu-DOTATATE IV once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial and undergo gallium Ga 68-DOTATATE PET/CT before treatment.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
Treatment (SBRT, 177Lu-DOTATATE)
Patients undergo SBRT over 5 fractions in the absence of disease progression or unacceptable toxicity. Starting 4-10 weeks after completion of SBRT, patients receive SOC 177Lu-DOTATATE IV once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial and undergo gallium Ga 68-DOTATATE PET/CT before treatment.
干预措施: Lutetium Lu 177 Dotatate (Drug)
Treatment (SBRT, 177Lu-DOTATATE)
Patients undergo SBRT over 5 fractions in the absence of disease progression or unacceptable toxicity. Starting 4-10 weeks after completion of SBRT, patients receive SOC 177Lu-DOTATATE IV once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial and undergo gallium Ga 68-DOTATATE PET/CT before treatment.
干预措施: Computed Tomography (Procedure)
Treatment (SBRT, 177Lu-DOTATATE)
Patients undergo SBRT over 5 fractions in the absence of disease progression or unacceptable toxicity. Starting 4-10 weeks after completion of SBRT, patients receive SOC 177Lu-DOTATATE IV once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial and undergo gallium Ga 68-DOTATATE PET/CT before treatment.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (SBRT, 177Lu-DOTATATE)
Patients undergo SBRT over 5 fractions in the absence of disease progression or unacceptable toxicity. Starting 4-10 weeks after completion of SBRT, patients receive SOC 177Lu-DOTATATE IV once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial and undergo gallium Ga 68-DOTATATE PET/CT before treatment.
干预措施: Gallium Ga 68-DOTATATE (Radiation)
Treatment (SBRT, 177Lu-DOTATATE)
Patients undergo SBRT over 5 fractions in the absence of disease progression or unacceptable toxicity. Starting 4-10 weeks after completion of SBRT, patients receive SOC 177Lu-DOTATATE IV once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial and undergo gallium Ga 68-DOTATATE PET/CT before treatment.
干预措施: Positron Emission Tomography (Procedure)
Treatment (SBRT, 177Lu-DOTATATE)
Patients undergo SBRT over 5 fractions in the absence of disease progression or unacceptable toxicity. Starting 4-10 weeks after completion of SBRT, patients receive SOC 177Lu-DOTATATE IV once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial and undergo gallium Ga 68-DOTATATE PET/CT before treatment.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Incidence of Acute Grade 3+ Non-Hematologic Adverse Events
时间窗: Within 3 months of therapy
Will evaluate acute grade 3+ non-hematologic toxicity (based on Common Terminology Criteria for Adverse Events version 5) compared to historical controls of peptide receptor radionuclide therapy alone. The list of non-hematologic acute grade 3+ treatment related adverse events will be summarized descriptively using frequencies and percentages of all captured toxicities by severity and relevance. An exact binomial test will then be used to compare the observed toxicity rate to the historical control rate, assessing if the observed rate significantly exceeds expected levels.
次要结局
- Incidence of Acute Grade 2+ Non-Hematologic Adverse Events(Up to 12 months)
- Response Rate(At 3 months)
- Progression Free Survival(At 12 months)
- Patient-Reported Health-Related Quality of Life(Up to 12 months)
研究者
Pretesh Patel
Principal Investigator
Emory University