Randomized Study of Carbon Ion Boost in Hypoxic Lesions Identified by 18F-Misonidazole PET/CT in Patients With Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Local progression-free survival
研究概览
简要总结
The goal of this randomized clinical trial is to learn about if carbon ion radiotherapy dose boost in hypoxia lesions detected by 18F-Misonidazole PET/CT could improve clinical outcomes in locally advanced non-small cell lung cancer patients compared with standard treatment protocol in our center. The patients will be randomly divided into two arms: standard treatment arm and hypoxic lesions dose boost arm. The standard treatment arm will receive carbon ion beam radiotherapy of 77Gy (RBE equivalent) per 22 fractions for gross tumor volume. The hypoxic lesions dose boost arm will receive 77Gy (RBE equivalent) per 22 fractions for gross tumor volume and a simultaneously dose boost of 83.6Gy (RBE equivalent) per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PET/CT.
Researchers will compare the local progression-free survival of two groups (primary endpoint), progression-free survival (secondary endpoint), overall survival (secondary endpoint), response rate (secondary endpoint), factional hypoxia volume (FHV) reduction rate (secondary endpoint) and toxicities (secondary endpoint).
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
- 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
- •Between the ages of 18 and
- •ECOG general status score of 0-2 .
- •Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, stage IIIa-IIIc (AJCC/UICC 8th edition). Largest diameter of primary tumor ≥ 4cm before carbon ion radiotherapy.
- •Medically inoperable, or patient refuses surgery.
- •Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥80 x 109/L, hemoglobin ≥9 g/dL 2). Lung function: FEV1>25%, DLCO>25% 3). Cardiac function: no serious pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, serious chronic heart disease and other complications that may affect radiotherapy.4). Adequate liver function: total bilirubin <1.5 times the upper limit of normal value, and AST, ALT<2 times the upper limit of normal value. 5). Adequate renal function: serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance ≥50 ml /min, and urinary protein <2+. Patients with a baseline urinary protein level of 2+ or more should have a 24-hour urine collection and evidence of a 24-hour urinary protein level of 1g or less.
- •Sign the informed consent.
排除标准
- •Patients with squamous cell carcinoma treated with bevacizumab before radiotherapy.
- •Patient fails to comply with the treatment protocol.
- •Complicated with other malignant tumors that have not been controlled.
- •Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.
- •Chest radiation therapy or radioactive particle implantation history.
- •Cardiac pacemakers or other internal metal prosthesis implants that may be affected by high-energy radiation or may affect the dose distribution to the radiation target area.
- •Pregnancy (confirmed by serum or urine β-HCG test) or lactation period.
- •HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.
- •A history of mental illness may hinder the completion of treatment.
- •With serious comorbidity that may interfere with radiotherapy, including: (a) Acute infectious diseases or acute active phase of chronic infection. b) Unstable angina pectoris, congestive heart failure, myocardial infarction that has been hospitalized in the past 6 months. c) Exacerbations of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization. d) Severely impaired immune function. e) Diseases with excessive sensitivity to radiation such as ataxia telangiectasia. f) Other diseases that may affect particle radiotherapy.
- •Other circumstances that the physician considers inappropriate to participate in clinical study.
研究组 & 干预措施
Standard treatment arm
The standard treatment arm will receive carbon ion beam radiotherapy of 77Gy (RBE equivalent) per 22 fractions for gross tumor volume.
干预措施: Standard carbon ion beam radiotherapy (Radiation)
Boost arm
Boost arm will receive 77Gy (RBE equivalent) per 22 fractions for gross tumor volume and a simultaneously dose boost of 83.6Gy (RBE equivalent) per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PET/CT
干预措施: Carbon ion beam radiotherapy simultaneously dose boost (Radiation)
结局指标
主要结局
Local progression-free survival
时间窗: From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months
Local progression-free survival was defined from the start of carbon ion radiotherapy till the date of local progression or the last follow-up
次要结局
- Overall response rate(From date of radiotherapy started until 6 months after first radiotherapy)
- Overall survival rate(From date of radiotherapy started until the date of death from any cause, assessed up to 100 months)
- Incidence of Treatment-induced Adverse Events(From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 months)
- Disease progression-free survival rate(From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Change of fractional hypoxia volume(From date of radiotherapy started until 1 month after first radiotherapy)
研究者
Jian Chen
Clinical Professor
Shanghai Proton and Heavy Ion Center