Adjuvant Treatment of Cancer of the Esophagus or Cardia Before Resection With Curative Intent. Comparative Study Between Chemotherapy and Radiochemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia.
研究概览
简要总结
The purpose of this randomized study is to clarify if neoadjuvant radiochemotherapy gives a higher degree of complete histological response than neoadjuvant chemotherapy before surgery in patients undergoing treatment for cancer of the esophagus or cardia.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically verified squamos cell carcinoma, adenocarcinoma of the esopohagus or gastric cardia (type II)
- •Tumor located in cervical oesophagus, not requiring laryngo-esophagectomy. Patients with performance status 0-1 axxording to WHO scale and with resectable tumours, as assessed at the prerandomisation evaluation
- •Adequate haemotological function, defined as having WBC > 3 x 10(9)/litre and platelets > 100 x 10 (9)/litre.
- •Adequate renal function defined as having normal serum creatinine level and/or calculated glomerular filtration rate > 60 ml/min.
- •Tumour stage: T1Ni, T2N0, T2N1, T3N0, T3N1, M1a
排除标准
- •Pregnancy and/or lactation. Women of childbearing ages can be included and provided that adequate contraceptive methods are used
- •Patients with diabetes complications (e.g. rethinopathy, neuropathy) as well as patients with uncontrolled cardiac disease or myocard infarction within 12 months are considered unsuitable for chemoradiotherapy.
- •Concomitant malignancy (< 5 years since diagnosis) that can interfere the interpretation of study results, ongoing antitumoral treatment.
- •Patients being unable tom comply with the protocol
- •Tumor stage T1 N0, T4 NX or TXNXM1b
研究组 & 干预措施
Radiochemotherapy
Arm I: Radiochemotherapy + Surgery
干预措施: Chemotherapy (Drug)
Radiochemotherapy
Arm I: Radiochemotherapy + Surgery
干预措施: Radiochemotherapy (Radiation)
Chemotherapy
Arm II: Chemotherapy + surgery
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia.
时间窗: Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy.
Chireac tumour regression grade
次要结局
- Safety of Respective Neoadjuvant Therapies.(Five years follow up)
- HRQOL and Swallowing Function(Entry study up to Five years follow up)
研究者
Magnus Nilsson
Ass Professor
Karolinska University Hospital