Recurrence-pattern-based Volume Versus Conventional-volume Stereotactic Body Radiation Therapy in Locally Advanced Pancreatic Cancer: an Open-label, Randomized, Phase 2 Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- 1-year Progression Free Survival Rate
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of a recurrence-pattern-based-volume versus conventional-volume stereotactic body radiation therapy for locally advanced pancreatic cancer, so as to determine whether the target delineation method based on recurrence pattern can obtain better survival benefits.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Cytologically or histologically verified pancreatic adenocarcinoma
- •Imaging examinations confirmed locally advanced pancreatic cancer
- •No previous radiotherapy, chemotherapy, immunotherapy or targeted therapy
- •ECOG of 0 to1
- •Age of 18 years or older
- •Adequate bone marrow function, defined as: Absolute neutrophil count (ANC) ≥ 1.5×10^9 cells/L, leukocyte count≥ 3.5×10^9 cells/L, platelets ≥ 70×10^9 cells/L, hemoglobin ≥ 8.0 g/dl
- •Adequate liver and renal, defined as: Albumin > 2.5 g/dL, total bilirubin < 3 mg/dL, creatinine < 2.0 mg/dL, AST<2.5 × ULN (Upper Limit of Normal) (0-64U/L), ALT<2.5 × ULN (0-64U/L)
- •Adequate blood clotting function, defined as: international normalized ratio (INR) < 2 (0.9-1.1)
- •Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
排除标准
- •Previously receiving radiotherapy, chemotherapy, immunotherapy or targeted therapy
- •Evidences of metastatic disease confirmed by chest CT or PET-CT
- •Age <18 years
- •Secondary malignancy
- •Abnormal results of blood routine examinations and liver and kidney and coagulation tests
- •Patients with active inflammatory bowel diseases or peptic ulcer
- •Gastrointestinal bleeding or perforation within 6 months
- •Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- •Medical history of symptomatic congestive heart failure: New York Heart Association Class III to IV
- •Medical history of respiratory insufficiency
- •Women who are pregnant or breastfeeding
- •Participation in another clinical treatment trial
- •Inability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document
研究组 & 干预措施
Arm A
A conventional-volume stereotactic body radiation therapy following gemcitabine and nab-paclitaxel
干预措施: SBRT (Radiation)
Arm A
A conventional-volume stereotactic body radiation therapy following gemcitabine and nab-paclitaxel
干预措施: Chemotherapy (Drug)
Arm B
A recurrence-pattern-based-volume stereotactic body radiation therapy following gemcitabine and nab-paclitaxel
干预措施: SBRT (Radiation)
Arm B
A recurrence-pattern-based-volume stereotactic body radiation therapy following gemcitabine and nab-paclitaxel
干预措施: Chemotherapy (Drug)
结局指标
主要结局
1-year Progression Free Survival Rate
时间窗: 1 year
The proportion of patients without disease progression at one year
次要结局
- Treatment-related Adverse Events(4 years)
- Progression Free Survival(4 years)
- Overall Survival(4 years)