ISRCTN29580179已完成未知
Phase III randomised, double-blind, placebo-controlled trial of Gefitinib (Iressa®) versus placebo in Oesophageal Cancer progressing after chemotherapy
niversity of Oxford (UK)0 个研究点目标入组 450 人开始时间: 2007年11月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 450
研究概览
简要总结
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24950987
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Prior to 26/10/09:
- •1. Aged greater than 18 years
- •2. Adenocarcinoma, squamous cell cancer or poorly differentiated cancer for Type I and Type II oesophageal cancer. NB: Patients with epithelial tumours of the oesophagus are eligible
- •3. Up to two prior regimens, either one as neoadjuvant plus one for advanced disease, or up to two for advanced disease
- •4. Creatinine clearance greater than 30 ml/min; alkaline phosphatase, bilirubin and Alanine aminotransferase (ALT) less than 2 x Upper Limit of Normal (ULN); haemoglobin greater than 10 g/dL
- •5. World Health Organization (WHO) performance Status 0, 1 or 2
- •6. Measurable or evaluable disease by Computerised Tomography (CT) scan
- •7. Able to swallow tablets
- •8. Patients with brain metastases must be stable and have received cranial irradiation prior to entry
- •9. Patients must complete the Quality Of Life (QOL) baseline questionnaire
- •Amended 26/10/09:
- •1. Aged greater than 18 years
- •2. Adenocarcinoma, squamous cell cancer or poorly differentiated cancer for Type I and Type II oesophageal cancer. NB: Patients with epithelial tumours of the oesophagus are eligible
- •3. Histologically proven adenocarcinoma, squamous cell cancer or poorly differentiated epithelial malignancy
- •4. Up to two prior regimens, either one as neoadjuvant plus one for advanced disease, or up to two for advanced disease [date of last administration of chemotherapy must be >6 weeks prior to randomisation]
- •5. World Health Organization (WHO) performance Status 0, 1 or 2
- •6. Measurable or evaluable disease by Computerised Tomography (CT) scan
- •7. Able to swallow tablets
- •8. Patients with brain metastases must be stable and have received cranial irradiation prior to entry
排除标准
- •Prior to 26/11/09:
- •1. Previous malignancy not treated curatively
- •2. Previous malignancy treated curatively less than 5 years ago
- •3. Medical condition considered to interfere with the safe participation in the trial
- •4. Radiotherapy to site of measurable or evaluable disease in the last month
- •5. Pregnancy
- •6. Not able to give written informed consent
- •Amended 26/101/09:
- •1. Presence of previous or other malignancy likely to confound results or interfere with gefitinib therapy
- •2. Medical condition considered to interfere with the safe participation in the trial
- •3. Radiotherapy to site of measurable or evaluable disease in the last 4 weeks
- •4. Pregnancy
- •5. Sexually active patients of child-bearing potential not using adequate contraception* (male and female) [post menopausal women must have been amenorrheic for at least 12 months to be considered as having non-child-bearing potential]
- •6. Serum bilirubin greater than 3 times the upper limit of reference range (ULRR)
- •7. Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) = 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases)
- •8. Any evidence of clinically active Interstitial Lung Disease (ILD) (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- •9. Known severe hypersensitivity to gefitinib or any of the excipients of this product
- •10. On other cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids) or experimental medications
- •* For female trial participants: birth control pills, approved contraceptive implant, spermicidal foam and condoms, intrauterine device, or prior tubal ligation. For male trial participants: condoms and spermicidal foams or prior vasectomy.
研究者
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