A Randomized Control Trial (RCT) of Using Iodine-125 Brachytherapy Versus Intensity-modulated Radiation Therapy (IMRT) to Treat Inoperable Salivary Gland Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- local control rate
研究概览
简要总结
- To compare the efficacy of Iodine-125 radioactive seeds implantation versus IMRT to treat inoperable salivary gland carcinoma.
- To compare the safety of Iodine-125 radioactive seeds implantation versus IMRT to treat inoperable salivary gland carcinoma.
详细描述
The target population are those patients with inoperable salivary gland derived primary or recurrent cancer, including local advanced primary salivary gland cancer which could not be resected completely; recurrent salivary gland cancer which could not be resected completely; T3/T4 tumor which could not tolerate surgery due to severe combined disease. The subjects would be divided into Iodine-125 radioactive seeds permanent interstitial implantation brachytherapy and intensity-modulated radiation therapy randomly. During the follow-up period, the efficacy and the safety index would be monitored.
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
- •Patients are diagnosed histologically as primary or recurrent salivary gland cancers that may occur in either major salivary glands or minor salivary glands.
- •The inoperable circumstance include: Primary or recurrent salivary gland cancers that could not be resected completely or could not get negative incision.
- •T3/T4 tumor patients with severe medical comorbidities could not accept the high risk of perioperative complications.
- •At least one measurable tumor or focus (according to RESIST 1.1 Standard).
- •Karnofsky score>
- •Survival time predicted ≥ 3months;
- •HGB≥9 g/dL, WBC≥3.0×10^9/L, NEUT≥1.5×10^9/L, platelet count (PLT)≥ 100×10^9/L; TBIL≤1.5 upper limit of normal, Alanine aminotransferase (ALT)/AST≤3 upper limit of normal; Cera≤1.5 upper limit of normal.
- •Male or female with fertility in the experiment are willing to take contraceptive measures.
排除标准
- •Radioactive therapy history of head and neck.
- •Suffering from other malignant tumor in recent five years, except skin basal cell carcinoma or carcinoma in situs of cervix.
- •Chemotherapy history.
- •Receiving other effective therapy.
- •Distant metastases.
- •Pathologic result as squamous cell carcinoma.
- •Neurological or mental abnormalities which affect cognitive ability.
- •Severe cardiovascular and cerebrovascular diseases, such as heart failure (NYHA III-IV class), uncontrolled coronary heart disease, cardiomyopathy, uncontrolled arrhythmias, uncontrolled hypertension, myocardial infarction or cerebral infarction within past six months.
- •Active serious clinical infections :> Class 2 NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) Version 4.0 within 14 days before randomization, including active tuberculosis.
- •HIV infection or active hepatitis B or hepatitis C.
- •Uncontrolled systemic diseases, such as poorly controlled diabetes mellitus.
- •Medical history of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or baseline chest X-ray / CT showed evidence of interstitial lung disease;
- •Pregnancy (via urine β-human chorionic gonadotropin test to determine) or breastfeeding.
结局指标
主要结局
local control rate
时间窗: 1 year
According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, tumor progressing during the treatment and follow up period means local control failure, which include the sum of diameters of local and region target focus increases ≥20% or ≥5mm; new focus emerges at local or region area; metastases or secondary primary tumor would not be concluded.
次要结局
- progression-free survival(2 years)
- overall survival(From date of randomization until the date of death from any cause, assessed up to 2 years)
研究者
Jianguo Zhang
Professor
Peking University