CTRI/2019/07/020388招募中3 期
PReCedeNT trial: Phase III randomised-controlled open-label trial of Lutetium - 177 Peptide Receptor Radionuclide Therapy (PRRT) Plus Chemotherapy Versus PRRT alone in FDG-avid, Well-Differentiated Gastro-Entero-Pancreatic Neuroendocrine Tumors (GEP-NETs) - PReCedeNT
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Histopathological diagnosis of GEP-NET
- •necessarily satisfying all the the criteria
- •2. Well differentiated G2 Ki67 more than 5-20%
- •and G3 ki67- greater than 20-55%
- •3. Well-differentiated G1 and G2 2 to5% with
- •disease progression in last 6 months
- •4. Positive Ga68 DOTANOC PETCT - Krennings
- •score more than equal to 3
- •5. Positive FDG PET imaging, grade 3 or 4 uptake
- •6.Locally advanced or inoperable disease or
- •metastatic disease
- •7. Karnofsky performance-status score of at
- •least 60 or ECOG performance status less
- •than or equal to 2
- •8. Life expectancy greater than 6 months
排除标准
- •1. Serum creatinine level of more than 1.6 mg
- •per dl or a creatinine clearance of less
- •than 50 ml per min
- •2. Hemoglobin level of less than 8.0 g per
- •3. Red blood cell count not less than
- •300,000 per cubic millimeter
- •4. White cell count of less than 2000 per cubic
- •5. Platelet count of less than 75,000 per cubic
- •6. Total bilirubin level of more than 3 times
- •the upper limit of the normal range
- •7. Serum albumin level more than 3.0 g per dl
- •8. Treatment with more than 30 mg of octreotide
- •LAR within 12 weeks before randomisation
- •9. Peptide receptor radionuclide therapy at any
- •time before randomisation
- •10.Pregnancy and Lactation
- •11.Patients with concurrent malignancies
研究者
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