NCT00420394Unknown2 期
Phase II Study of Preoperative Chemotherapy and Postoperative Chemo-Radiation for Newly Diagnosed, Potentially Resectable Gastric Cancer
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of the study regimen.
研究概览
简要总结
Rationale: Adjuvant chemoradiation considered as standard of care after curative surgery for adenocarcinoma of stomach and gastroesophageal cancer. Preoperative chemotherapy in the in locally advanced gastric cancer results in significant tumoral downstaging with improved rate of curative resections.
Purpose: To evaluate feasibility and safety of combination of preoperative chemotherapy and postoperative chemoradiation for locally advanced adenocarcinoma of stomach and gastroesophageal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of stomach or gastro-esophageal junction.
- •T2-4 N0-3 M
- •T1 tumors are eligible if T1N1-3
- •Disease must be clinically limited to the stomach or GEJ.
- •Pre-treatment Port-a-Cath insertion obligatory
- •No prior chemotherapy.
- •No prior radiotherapy.
- •Patients must be surgical candidates as determined by the treating surgeon.
- •Adequate organ function defined as:
- •Patients must have an ECOG Performance Status <
- •Patients must be able to sign the informed consent document.
排除标准
- •Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
- •Patients with primary carcinomas of the esophagus.
- •Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
- •Patients with evidence of metastatic disease are not eligible.
- •New York Heart Association Class III or IV heart disease.
- •Severe co-morbid conditions or nonmalignant illness whose control may be jeopardized by complications of the study treatment.
- •Pregnant or lactating women or men unable or unwilling to practice contraception are excluded.
- •Any history of prior malignancy (other than non-melanoma skin cancer, in-situ cervical cancer, or superficial transitional cell bladder cancer).
- •Clinically significant hearing loss.
- •Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
- •Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.
- •Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study
结局指标
主要结局
Feasibility of the study regimen.
次要结局
- Rate of R0 resection following chemotherapy.
- Morbidity and mortality of surgery following chemotherapy.
- Overall and progression free survival following the study treatment plan
研究者
研究点 (2)
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