A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
研究概览
详细说明
It has been shown recently in a study conducted in the USA (INT0116) that postoperative, adjuvant chemoradiotherapy improves survival for patients with gastric cancer. This treatment is relatively new and there remains debate regarding the optimal chemotherapy regimen and the optimal method of radiotherapy delivery. This study will evaluate a new regimen of adjuvant chemoradiotherapy for gastric cancer that employs ECF chemotherapy as the systemic component given before and after concurrent chemoradiation with continuous infusional 5-fluorouracil. Patients receive one cycle of ECF, followed 28 days later by chemoradiotherapy to a radiation dose of 45 Gy in 25 fractions over 5 weeks, and then one month later two further cycles of ECF are given. All patients are treated using multiple-field conformal radiation techniques.
The specific objectives of the study are:
- To detail the acute toxicity associated with this treatment.
- To determine the feasibility of the proposed concurrent chemoradiation regimen.
- To determine the feasibility of a standardized technique for radiation treatment planning and delivery.
The study will help to develop a common approach to the adjuvant treatment of gastric cancer, which is required before initiating further clinical trials in gastric cancer.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Christchurch、新西兰、4710
- Christchurch Hospital
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New South Wales
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Liverpool、New South Wales、澳大利亚、1871
- Liverpool Hospital
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Newcastle、New South Wales、澳大利亚、2298
- Calvary Mater Newcastle
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Penrith、New South Wales、澳大利亚、2751
- Nepean Cancer Care Centre
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Randwick、New South Wales、澳大利亚、2031
- Prince of Wales Hospital
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Sydney、New South Wales、澳大利亚、2145
- Westmead Hospital
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Sydney、New South Wales、澳大利亚、2050
- Royal Prince Alfred Hospital
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Sydney、New South Wales、澳大利亚、2069
- Royal North Shore Hospital
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Queensland
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Brisbane、Queensland、澳大利亚
- Mater QRI
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Herston、Queensland、澳大利亚、4029
- Royal Brisbane Hospital
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Tugun、Queensland、澳大利亚、4224
- East Coast Cancer Centre
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Woolloongabba、Queensland、澳大利亚、4102
- Princess Alexandra Hospital
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Tasmania
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Launceston、Tasmania、澳大利亚、7250
- Launceston General Hospital
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Victoria
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Box Hill、Victoria、澳大利亚
- Box Hill Hospital
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Geelong、Victoria、澳大利亚、3220
- Andrew Love Cancer Care Centre, Geelong Hospital
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Melbourne、Victoria、澳大利亚、3081
- Austin Health
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Melbourne、Victoria、澳大利亚、8006
- Peter Maccallum Cancer Centre
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Prahran、Victoria、澳大利亚、3181
- Alfred Hospital
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Western Australia
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Perth、Western Australia、澳大利亚、6009
- Sir Charles Gairdner Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
All of the following must apply:
Histologically proven adenocarcinoma of the stomach or gastro-oesophageal junction that is:
- completely resected with negative margins
- Stage T3,4 and/or N1,2 patients who have undergone a D2 nodal dissection can be entered on the study at the discretion of the treating clinician.
- Age greater than or equal to 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
Adequate organ function defined as follows:
- Bone marrow: Haemoglobin greater than or equal to 90 g/L; Neutrophil count greater than or equal to 1.5 x 10^9 /L; Platelet count greater than or equal to 100 x 10^9 /L
- Hepatic: Serum bilirubin less than or equal to 1.5 x ULN; AST and/or ALT less than or equal to 3.0 x ULN;
- Renal: Serum creatinine less than or equal to 0.150 mmol/L, and calculated creatinine clearance greater than or equal to 50mL/min.
- Adequate oral nutrition (intake greater than or equal to 1500 calories/day). This is to be assessed by a dietician prior to commencing treatment.
- Disease which can be radically treated to 45 Gy with standard fractionation.
- Patient able to be treated with infusional 5-fluorouracil (5-FU) and ECF chemotherapy.
- Written informed consent
Exclusion Criteria:
None of the following must apply:
- Evidence of metastatic disease.
- Prior chemotherapy or radiotherapy
- Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled.
- Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures.
Cardiac failure (relevant to the use of epirubicin):
- Patients with myocardial infarction within the last 6 months;
- Patients with New York Heart Association class III/IV congestive heart failure
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1
Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)
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50mg/m2 IV day 1
其他名称:
60mg/m2 IV day 1
其他名称:
5-FU 200mg/m2/d IV 21 day continuous infusion Cont.
infusional 5-FU 225mg/m2/day, 7 days/wk throughout entire period RT via CADD pump through PICC line
其他名称:
45Gy 25 Fractions, 5 days/week for 5 weeks
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity
大体时间:Final analysis will be at 3 years.
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Final analysis will be at 3 years.
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The percentage of patients who complete the planned chemoradiation protocol
大体时间:Final analysis will be at 3 years.
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Final analysis will be at 3 years.
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The percentage of major radiotherapy protocol violations
大体时间:Final analysis will be at 3 years.
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Final analysis will be at 3 years.
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次要结果测量
结果测量 |
大体时间 |
---|---|
Median survival and overall survival at 3 years
大体时间:3 years
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3 years
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合作者和调查者
调查人员
- 学习椅:Trevor Leong、Peter MacCallum Cancer Centre, Australia
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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