Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.
试验速览
- 阶段
- 3 期
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
This study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not.
详细描述
For the esophageal carcinoma in II~III stage, routine dosage of Paclitaxel and platinum medicine chemotherapy concurrently radical radiotherapy is worthy to be studied. On this base, we advanced approach the enlarged field radiotherapy and the intervention of Tarceva. And we approach the therapeutic effect for this method theoretically, which may give a further reasonable guidance for the clinical therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Subjects must be confirmed Esophageal Carcinoma pathologically
- •(EUS)I～IVa, without contraindication for radical radiotherapy
- •Subjects haven't been given neither radiotherapy nor chemotherapy before
- •Age 18-70,behavioral status evaluation ECOG scores 0-2 and anticipated survival more than 6 months
- •In 7 days after being selected, subjects should follow the status: WBC ≥ 4.0 x 10^9/L; ANC ≥ 1.5x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN
- •Subjects should sign for the informed consent
- •Subjects should perform good compliance
- •Male and female subjects who have the ability of fertility should take contraception during the whole course and also 3 months after last dosage.In 7 days before the inclusion, urine pregnancy tests of subjects should be negative.
排除标准
- •Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
- •Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- •Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years
- •Patients who multiple foci esophagus
- •Patients who are/were given any other medicine tests currently/in last 4 weeks
- •Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
- •Women in status of pregnancy
- •Patients who have complications exist as following:
- •(1)Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2)A history of myocardial infarction in the past 6 months; (3)There is a need for antibiotic treatment of acute bacterial or fungal infection; (4)Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5)Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6)Uncontrollable seizures, or loss of insight because of mental illness
研究组 & 干预措施
A
Enlarged field + Paclitaxel + Cisplatin + Tarceva
干预措施: Paclitaxel (Drug)
A
Enlarged field + Paclitaxel + Cisplatin + Tarceva
干预措施: Cisplatin (Drug)
A
Enlarged field + Paclitaxel + Cisplatin + Tarceva
干预措施: Tarceva (Drug)
A
Enlarged field + Paclitaxel + Cisplatin + Tarceva
干预措施: Radiotherapy (Radiation)
B
Enlarged field + Paclitaxel + Cisplatin
干预措施: Paclitaxel (Drug)
B
Enlarged field + Paclitaxel + Cisplatin
干预措施: Cisplatin (Drug)
B
Enlarged field + Paclitaxel + Cisplatin
干预措施: Radiotherapy (Radiation)
C
Conventional field + Paclitaxel + Cisplatin + Tarceva
干预措施: Paclitaxel (Drug)
C
Conventional field + Paclitaxel + Cisplatin + Tarceva
干预措施: Cisplatin (Drug)
C
Conventional field + Paclitaxel + Cisplatin + Tarceva
干预措施: Tarceva (Drug)
C
Conventional field + Paclitaxel + Cisplatin + Tarceva
干预措施: Radiotherapy (Radiation)
D
Conventional field + Paclitaxel + Cisplatin
干预措施: Paclitaxel (Drug)
D
Conventional field + Paclitaxel + Cisplatin
干预措施: Cisplatin (Drug)
D
Conventional field + Paclitaxel + Cisplatin
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
overall survival
时间窗: five years after enrollment
failure: death from any cause
次要结局
- Progression-free survival(five years after enrollment)
- local-regional control rate(three years after enrollment)
- Adverse events(five years after enrollment)
- Health-related quality of life(five years after enrollment)
研究者
Wu Shixiu
Professor
Wenzhou Medical University