A Phase II Study With Oxaliplatin + 5-FU + Ceuximab and Radiotherapy for the Treatment of Non-resectable, Locally Advanced But Not Metastatic Cancer of Oesophagus or the Cardia.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 51
- 主要终点
- Local tumour Control
研究概览
简要总结
In patients with esophageal cancer, treatment with curative intent can be given to medically fit patients without distant metastases. It may consist of chemoradiotherapy or surgery alone or in combination. Surgery in combination with chemotherapy is another option. For patients who are not medically fit for surgery or with unresectable invasion in adjacent structures the only alternative with curative intent is, with current knowledge, definitive chemoradiotherapy. In the current study the investigators aim to improve prognosis for patients not suitable for surgery. Patients receive treatment with conventional chemoradiotherapy (oxaliplatin, fluorouracil and radiotherapy) with the addition of a more recently developed drug, an antibody called cetuximab.
详细描述
Patients are treated with three cycles of oxaliplatin and fluorouracil 750 mg/m2/24 hours, day 1-5. Each cycle lasts for 21 days. Oxaliplatin is given with 130 mg/m2 in the first cycle and in cycle 2 and 3 which are administered concomitant with radiotherapy the dose is reduced to 85 mg/m2.
A loading dose of cetuximab 400 mg/m2 is given one week before the start of radiotherapy, and thereafter 250 mg/m2 is given weekly during the course of radiotherapy.
Concomitant with chemotherapy radiotherapy to a total dose of 50 Gy is given (2 Gy once daily in 25 fractions, 5 days a week) with a photon beam linear accelerator.
After treatment patients are followed every 6 months for three years with clinical examination and a CT-scan.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •Histological verified squamos cell carcinoma or adenocarcinoma of the oesophagus or cardia
- •Performance status WHO 0-2, age 18-75 years
- •Locally advanced disease, non-resectable (T4 N0-N3 M0) or disease which is not operable for any other reason (T2/T3 N0-N3 M0)
- •Adequate hematological, liver and renal function
- •Written informed consent
排除标准
- •Distant metastases
- •Prior chemotherapy or radiotherapy for oesophageal cancer or cancer of the cardia
- •Symptomatic peripheral neuropathy equal to or greater than NCI grade 2
- •Other concomitant serious illness or medical condition that would not permit the patient to complete the study treatment or sign the informed consent
- •Myocardial infarction within 6 months prior to study entry
- •Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) unless treated, in remission and off active treatment for greater than 2 years
- •Pregnancy
研究组 & 干预措施
Cetuximab
Cetuximab is administered once a week. The initial dose is 400 mg/m2 body surface area. First Cetuximab infusion should start day 15 in cycle 1.The subsequent weekly doses are 250 mg/m2.
干预措施: Cetuximab (Drug)
结局指标
主要结局
Local tumour Control
时间窗: 1 year
Local tumour control will be measured with a computed tomography
次要结局
- Progression-free survival(3 years)
- Overall and disease-free survival(3 years)
- Toxicity(3 years)
- Patterns of relapse(3 years)
- Quality of life(3 years)
研究者
Gabriella Alexandersson von Döbeln
Medical doctor
Karolinska University Hospital