NCT05830019招募中不适用
Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post Surgery
Shanghai Proton and Heavy Ion Center1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2021年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- local progression-free survival
研究概览
简要总结
The aim of this study is to evaluate the toxicity and tolerance of carbon ion radiotherapy for recurrent pancreatic carcinoma post surgery
详细描述
The carbon dose of 67.5 Gy equivalent in 15 fractions was delivered to clinical target volume (CTV). The dose limiting toxicity (DLT) was defined as CTCAE grade 3 or higher of non-hematological toxicity (G3). The acute and late toxicities, overall survival (OS), progression-free survival (PFS), local progression-free survival (LPFS) and distant metastasis-free survival (DMFS) were the endpoints.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The histologically or cytologically confirmed pancreatic adenocarcinoma;
- •Local-regional recurrent pancreatic cancer post surgery, no evidence of distant metastases, based upon Positron Emission Tomography, CT, or MRI images of the chest, abdomen and pelvis within 30 days prior to registration;
- •Eastern Cooperative Oncology Group Performance Status 0-1 within 30 days prior to registration;
- •Age of ≥ 18 years old;
- •Enough hematological function (white blood cell count ≥ 3.0×109/L; platelets ≥50×109/L; hemoglobin ≥ 90 g/L);
- •Enough liver and kidney functions (creatinine <110gmol/L; urea nitrogen <7.1mmol/L; bilirubin < 1.5 x ULN, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN);
- •Informed consent form obtained.
排除标准
- •Eastern Cooperative Oncology Group Performance Status >=2；
- •Liver, kidney and bone marrow function are poor and not adequate for treatment;
- •GI was invaded by recurrent lesions;
- •Prior radiation therapy to the abdomen or radioactive particle implantation or other local treatment for the recurrent lesions;
- •Cardiac pacemaker or other metal implantation whose function may be disturbed by high energy beam or which affect the dose in target volume;
- •Dose constrain of normal liver, digested system and other organ at risk could not reach the expecting safe dose constrain;
- •The patient could not get benefit from proton or heavy ion radiotherapy in physician's opinion;
- •Comitant diseases which could affect the proton or heavy ion radiotherapy;
- •Pregnancy（blood or urine β-human chorionic gonadotropin certified）or lactation;
- •Drug or alcohol abused;
- •HIV positive, including received anti-retrovirus treatment; chronic hepatitis B virus replication stage; hepatitis C active stage; syphilis active stage;
- •hepatitis B virus positive, hepatitis B virus replication stage, need to be treated with anti-virus treatment, but could not receive anti-virus treatment because of comitant disease;
- •Psychiatric history, possibly affecting the completion of treatment;
- •Patients with serious complications that might affect radiotherapy， including 1）unstable angina pectoris requiring hospitalization in the last 6 months，congestive heart failure，myocardial infarction； 2）acute bacterial or systemic fungal infections； 3）exacerbation of chronic obstructive pulmonary disease ( COPD) or other respiratory system disease requiring hospitalization 4）hepatic function insufficiency or renal function insufficiency 5） immunosuppressed patients
- •patients with connective tissue disease such as active scleroderma or lupus and so on, which is contraindication for radiotherapy
- •patients can't understand treatment goal or unwilling/unable to sign up inform consent form；
- •no civil capability or limited civil capacity.
结局指标
主要结局
local progression-free survival
时间窗: 2 years
local progression-free survival
次要结局
- overall survival rate(2 years)
- progression-free survival(2 years)
- adverse events(3 years)
研究者
Guoliang Jiang
director of clinical technical committee, professor
Shanghai Proton and Heavy Ion Center
研究点 (1)
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