Carbon Ion Radiotherapy in Frail Patients With Pancreatic Cancer: A Prospective Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Overall survival in frail patients with pancreatic cancer receiving carbon ion radiotherapy
研究概览
简要总结
"This prospective, single-arm phase II study aims to evaluate the efficacy and safety of carbon ion radiotherapy in frail patients with histologically confirmed, non-metastatic pancreatic cancer who are not eligible for surgery or systemic chemotherapy. Frail status is defined as a Clinical Frailty Scale (CFS) score ≥4 or the presence of significant medical comorbidities limiting aggressive treatment.
Carbon ion radiotherapy, known for its superior dose distribution and high linear energy transfer, may offer improved tumor control with acceptable toxicity in this vulnerable population. This study will assess overall survival, progression-free survival, local control, toxicity, and quality of life.
详细描述
"This prospective, single-arm phase II study evaluates the efficacy and safety of carbon ion radiotherapy in frail patients with non-metastatic pancreatic cancer who are not eligible for surgery or systemic chemotherapy due to a Clinical Frailty Scale (CFS) score ≥4 or significant medical comorbidities. carbon ion radiotherapy provides superior dose distribution and higher biological effectiveness compared with conventional X-ray radiotherapy, offering a potentially effective treatment option for this clinically vulnerable population.
Participants will undergo baseline evaluations including imaging (CT/MRI/PET-CT), laboratory tests, tumor markers, frailty assessment, and quality-of-life questionnaires (EORTC QLQ-C30 and FACT-Hep). Carbon ion radiotherapy will be delivered using 4D-CT-based planning, with either 55.2 Gy (RBE) in 12 fractions or 40-48 Gy (RBE) in 4 fractions. Target volumes include the primary tumor and high-risk peripancreatic regions, while organs-at-risk such as the stomach, duodenum, bowel, liver, kidneys, and spinal cord follow strict dose constraints. Weekly on-treatment assessments will monitor acute toxicity using CTCAE v5.0, and adaptive planning will be performed if needed.
Post-treatment follow-up will occur at 1-3 months and every 3-6 months thereafter for up to 2 years, including imaging, toxicity evaluation, tumor marker assessment, and repeated QOL surveys.
The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local control, treatment-related toxicity, quality of life, and tumor marker changes. Survival analyses will use Kaplan-Meier and Cox regression methods, and quality-of-life and toxicity outcomes will be summarized descriptively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study with no blinding. All participants and investigators are aware of the assigned intervention.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Histologically confirmed pancreatic cancer without distant metastasis.
- •Not eligible for surgery or systemic chemotherapy, defined as:
- •Clinical Frailty Scale (CFS) score ≥ 4, or Significant medical comorbidities precluding standard treatment. Patients who decline surgery and chemotherapy after adequate counseling. Age ≥ 19 years. Able to provide written informed consent. Eligible and willing to receive carbon ion radiotherapy.
排除标准
- •Age < 19 years. Presence of distant metastasis at baseline imaging (CT/MRI/PET-CT). Active or uncontrolled infection that may interfere with treatment. Active bleeding or bleeding tendency requiring immediate medical intervention. Pregnant or breastfeeding women. Any condition that, in the investigator's judgment, makes participation unsafe or inappropriate (e.g., severe organ dysfunction preventing radiotherapy).
- •Inability to comply with study procedures or follow-up schedule.
研究组 & 干预措施
Carbon Ion Radiotherapy
Participants receive carbon ion radiotherapy delivered either as 55.2 Gy in 12 fractions over 3 weeks or 40-48 Gy in 4 fractions over 1 week. Treatment planning includes 4D-CT-based simulation, defined target volumes (GTV/CTV), and organ-at-risk dose constraints. Radiotherapy is administered with daily or alternate-day fractionation depending on the selected regimen.
干预措施: Carbon Ion Radiotherapy (Other)
结局指标
主要结局
Overall survival in frail patients with pancreatic cancer receiving carbon ion radiotherapy
时间窗: Up to 2 years from the start of treatment
Overall survival will be assessed from the date of treatment initiation to death from any cause. The study will determine whether carbon ion radiotherapy provides a clinically meaningful improvement in survival compared with historical outcomes in frail patients with pancreatic cancer who previously received only supportive care or conventional X-ray radiotherapy.
Overall survival in frail patients with pancreatic cancer receiving carbon ion radiotherapy
时间窗: Up to 2 years from the start of treatment
Overall survival will be assessed from the date of treatment initiation to death from any cause. The study will determine whether carbon ion radiotherapy provides a clinically meaningful improvement in survival compared with historical outcomes in frail patients with pancreatic cancer who previously received only supportive care or conventional X-ray radiotherapy.
次要结局
- Quality of Life: FACT-Hep Score(Baseline, end of radiotherapy, and every 3-6 months up to 2 years)
- Local control rate(Up to 2 years from the start of treatment)
- Treatment-related toxicity(During radiotherapy and every 3-6 months up to 2 years)
- Tumor marker changes (CA 19-9, CEA)(Baseline and every follow-up visit up to 2 years)
- Progression-free survival(Up to 2 years from the start of treatment)
- Local control rate(Up to 2 years from the start of treatment)
- Quality of Life: EORTC QLQ-C30 Score(Baseline, end of radiotherapy, and every 3-6 months up to 2 years)
- Treatment-related toxicity(During radiotherapy and every 3-6 months up to 2 years)
- Tumor marker changes (CA 19-9, CEA)(Baseline and every follow-up visit up to 2 years)
- Quality of Life: FACT-Hep Score(Baseline, end of radiotherapy, and every 3-6 months up to 2 years)