Hypofractionated Radiotherapy Combined With Concurrent Weekly Chemotherapy and Thymosin α1 in Patients With Unresectable or Recurrent Thymic Epithelial Tumor: A Prospective, Single-arm Phase II Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This phase II study was to assess the efficacy and toxicity of hypofractionated radiotherapy (HRT) combined with weekly docetaxel/platinum and thymosin α1 in patients with unresectable or recurrent thymic epithelia tumors (TETs).
详细描述
HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.
All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .
Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic confirmation of thymoma, thymic carcinoma or thymic endocrine tumors.
- •Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Unresectable disease or recurrent intrathoracic disease which could be encompassed within radiation fields.
- •White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN.
- •FEV1 >0.8 L
- •CB6 within normal limits
- •Patients and their family signed the informed consents
排除标准
- •Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ.
- •Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia).
- •Malignant pleural effusion or pericardial effusion.
- •Weight loss >10% within the past 3 months.
- •Recruited in other clinical trials within 30 days
- •Drug addiction, long-term alcohol abuse and AIDS patients.
- •Uncontrollable epileptic attack or psychotic patients without self-control ability.
- •Severe allergy or idiosyncrasy.
- •Not suitable for this study judged by researchers.
研究组 & 干预措施
Expeiment
HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.
All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .
Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
干预措施: Thymosin a1 (Drug)
Expeiment
HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.
All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .
Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
干预措施: hypofractionated radiotherapy (Radiation)
Expeiment
HRT using the IMRT technique was administered. For patients with limited pulmonary or pleural metastases (≤3 lesions), stereotactic body radiation therapy (SBRT) could be used.
All patients received weekly docetaxel(25mg/㎡) and nedaplatin or cisplatin (25mg/㎡), each of 1 day's duration, concurrently with hypofractionated radiotherapy .
Meanwhile they received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
干预措施: concurrent chemoradiotherapy (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: 2 years
次要结局
- Overall Survival(2 years)
- Quality of Life score(1 year)
研究者
Hui Liu
Professor
Sun Yat-sen University