Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acute toxicity profiles, graded according to the NCI CTCAE version 3.0
研究概览
简要总结
The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and safety of customized CCT regimens based on the gene targets of SGTs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
- •Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
- •Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
- •No evidence of distant metastases
- •No synchronous or concurrent head and neck primary tumors
- •Karnofsky score over 60
- •Adequate organ function including the following:
- •Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
- •Platelets count >= 100 * 10^9/l
- •Hemoglobin >= 10 g/dl
- •AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
- •Total bilirubin <= 1.5 times institutional ULN
- •Creatinine clearance >= 50 ml/min
- •Serum creatine <= 1 times ULN
- •Signed written informed consent
排除标准
- •Evidence of distant metastasis
- •Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- •Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- •Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- •Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
研究组 & 干预措施
Pemetrexed arm
Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug.
干预措施: Intensity-modulated radiotherapy (Radiation)
Pemetrexed arm
Concurrent chemotherapy with Pemetrexed if genetic testing show that the patient should be sensitive to this drug.
干预措施: Pemetrexed (Drug)
Docetaxel arm
Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug.
干预措施: Docetaxel (Drug)
Docetaxel arm
Concurrent chemotherapy with Docetaxel if genetic testing show that the patient should be sensitive to this drug.
干预措施: Intensity-modulated radiotherapy (Radiation)
Cisplatin arm
Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel
干预措施: Intensity-modulated radiotherapy (Radiation)
Cisplatin arm
Concurrent chemotherapy with Cisplatin if genetic testing show that the patient was nor sensitive to neither Pemetrexed nor Docetaxel
干预措施: Cisplatin (Drug)
结局指标
主要结局
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0
时间窗: up to 6 weeks
次要结局
- Disease-free survival(2 years)
研究者
Guopei Zhu
MD
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University