To Observe the Local Tumor Recurrence Rate of Adding Intraluminal Brachytherapy With Balloon Applicator After Standard Definitive Concurrent Chemoradiotherapy (CCRT) on Local-regional Thoracic Esophageal Cancer Patients Who Refused Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- To estimate the local control rate at primary tumor site
研究概览
简要总结
Clinical experience of adding intraluminal brachytherapy with traditional applicator after definitive concurrent chemoradiotherapy (CCRT) for local-regional thoracic esophageal cancer is limited due to high complication risk and non-superiority in survival. The innovative applicator can maximize the therapeutic efficacy by reducing dose inhomogeneity in the esophageal wall, which will translate into less over-dosing and less risk of the side effects of fistula or stenosis.
The primary goal of this study by using new applicator is to observe the change in local tumor control rate, while secondary goals are treatment related toxicity, progression-free survival, and overall survival.
详细描述
American Brachytherapy Society (ABS) provided guidelines for brachytherapy in esophageal cancer in 1997, which defines the general principle for brachytherapy used in definitive CCRT. (1) Patients with unifocal thoracic adeno- or squamous cancers < or = 10 cm in length, with no evidence of intra-abdominal or metastatic disease.
(2) Contraindications include tracheal or bronchial involvement, cervical esophagus location, or stenosis that cannot be bypassed.
(3) The esophageal brachytherapy applicator should have an external diameter of 6-10 mm.
(4) If 5FU-based chemotherapy and 45-50-Gy EBRT are used, recommended brachytherapy is HDR 5-10 Gy in one to two weekly fractions of 5 Gy each and should not be given concurrently with chemotherapy In the esophageal cancer treatments, tumor recurrence in the primary tumor site approaches 50% in most non-surgical CCRT series reported. Brachytherapy has the advantages of introducing higher doses to the tumor site to improve tumor control, but it is like the double edge of the sword, higher dose may bring higher risk of serious side effect, such as fistula formation in the esophagus noted over previous studies. The innovative Braxx applicator can maximize the therapeutic efficacy by reducing dose inhomogeneity in the esophageal wall (3mm to surface: 136-175%), which will translate into less over-dosing and less risk of the side effects of fistula or stenosis as noted in traditional brachytherapy using NG tube (3mm to surface: 160%-265%). Without much changing the user's habits in performing brachytherapy, the innovative applicator is expected to be easier to be accepted for use.
* Screening Phase: All non-T4b or M1 (non-nodal organ involvement) stage esophageal cancer participants who received neoadjuvant/ definitive chemoradiation first, which includes radiotherapy dosage between 4140-5040cGy concurrently with chemotherapy of carboplatin + paclitaxel or cisplatin + 5FU.
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
- 20 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 20-85 years, with ECOG performance 0-2
- •Thoracic esophageal cancer with clinical stage I-III and biopsy proof; patient with cervical esophageal cancer or stage IV thoracic esophageal cancer could be recruited in this trial according to Investigator's assessment.
- •Complete first course CCRT with minimum doses of 40 Gy to tumor and nodal area via external beam radiotherapy (EBRT).
- •Patient whose tumor is resectable but declined to receive surgery after first course CCRT.
排除标准
- •T4b tumor status (tracheal / bronchial mucosa, aortic involvement, or fistula formation).
- •Stenosis of esophageal lumen that cannot be bypassed by the applicator.
- •The primary tumor length exceeds 20cm.
- •The patient is participating in other clinical trials.
结局指标
主要结局
To estimate the local control rate at primary tumor site
时间窗: 12 months after completion of treatment
Enrolled subject will be followed every 3 months after treatment, EGD-endoscope (± biopsy) will be arranged at Month 3, 6, 9, 12 and CT scans on Month 6, 12, to evaluate the tumor status.
次要结局
- Treatment toxicity grading according to the CTCAE(12 months after completion of treatment)
