A Phase II Trial of Postoperative Chemotherapy and Chemo-radiotherapy for Resected Adenocarcinoma of the Stomach and Gastro-esophageal Junction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- The proportion of patients completing protocol therapy (feasibility)
研究概览
简要总结
This study will determine the feasibility of adjuvant chemotherapy and chemo-radiotherapy for patients with surgically resected adenocarcinoma of the stomach and gastro-esophageal junction.
详细描述
Patients with localized gastric cancer often relapse either locally or systemically. A strategy to reduce relapses at common sites would be beneficial. Our prior trial has proved the feasibility of administering FOLFIRI regimen as adjuvant chemotherapy combined with adjuvant chemoradiation in patients with excised with curative intend gastric cancer. It would be important to improve the treatment involving active regimen as adjuvant chemotherapy and optimizing chemoradiation by introducing capecitabine as a radiosensitizer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with radically resected adenocarcinoma of the stomach and/or gastroesophageal junction with histologic proof of adenocarcinoma, pathologically staged T2-3, any N, M0
- •No prior radiation therapy to the stomach or immunotherapy or chemotherapy for any reason
- •Patients must have a life expectancy of at least 16 weeks and a performance status of < 2 ECOG scale
- •Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study.
- •Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of > 2.000/µL, and platelet count of > 100.000/µL), adequate liver function (bilirubin < 1,5 mg/dl), and adequate renal function (creatinine < 1,5 mg/dl
- •Patients must be able to understand the nature of this study and give written informed consent
排除标准
- •Patients with T1N0 carcinoma
- •Positive cytology of pleural, or pericardial effusion or patients with any peritoneal disease diagnosed intra-operatively)
- •Biopsy proof of lymph node metastases outside the study field such as supraclavicular, mediastinal, or para-aortic nodes
- •Evidence of metastatic disease to distant organs
- •Patients with cardiac disease graded as New York Heart Association Class III or IV, severe uncontrolled diabetes, hypertension, cerebron-vascular disease, or infection
- •Patients with diabetic neuropathy
- •Abnormalities of mental status such that either the patient cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements
- •Presence of concurrent or previous malignancies in the past 5 years (except for resected squamous or basal cell carcinoma of the skin)
- •Pregnant women are excluded from study entry due to the teratogenic effects of the study treatment
研究组 & 干预措施
1
TCX ->RT -> TCX
干预措施: Docetaxel (Drug)
1
TCX ->RT -> TCX
干预措施: Cisplatin (Drug)
1
TCX ->RT -> TCX
干预措施: Capecitabine (Drug)
1
TCX ->RT -> TCX
干预措施: Radiation (Radiation)
结局指标
主要结局
The proportion of patients completing protocol therapy (feasibility)
时间窗: The feasibility will be defined as the proportion of patients who receive adjuvant chemotherapy and chemo-radiation over total registered
次要结局
- Toxicity profile(Toxicity assessment on each chemotherapy cycle)
- Overall survival(1 year)