EUCTR2007-001987-55-ES进行中（未招募）不适用
A randomised trial assessing whether preoperative chemotherapy improves outcome in high-risk operable colon cancer - FOxTROT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,050
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Histologically proven adenocarcinoma of the colon or high grade dysplasia on histology plus unequivocal radiological evidence of invasive cancer
- •- A candidate for adjuvant oxaliplatin/ fluoropyrimidine chemotherapy based on:
- •Either radiological high risk (rT4 or rT3 tumour with extramural extension ? 5mm)
- •Or radiological intermediate risk (rT3 tumour with <5mm extramural extension) and younger age/good general health
- •- Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma, and when recovered to a fitness level consistent with the other eligibility criteria
- •- Adequate full blood count: WBC >3.0 x109/l; Plts >100 x109/l. Anaemia (Hb < 10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy
- •- Adequate renal biochemistry: GFR >50 ml/min calculated by the Wright or Cockroft formula or EDTA clearance >70 ml/min
- •- Adequate hepatobiliary function: bilirubin < 25 ?mol/l
- •- Aged 18 or over
- •- WHO performance status of 0, 1 or 2
- •- If female and of childbearing potential, must:
- •Have a negative pregnancy test ?72hours prior to initiating study treatment
- •Agree to avoid pregnancy during and for 6 months after study treatment
- •- If male with a partner of childbearing potential, must:
- •Agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment
- •- Patient able and willing to provide written informed consent for the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1020
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Any patient for whom radiotherapy is advised by the MDT
- •- Strong evidence of distant metastases or peritoneal nodules (M1)
- •- Peritonitis (secondary to perforated tumour)
- •- Colonic obstruction that has not been defunctioned
- •- Serious medical comorbidity, eg uncontrolled inflammatory bowel disease, uncontrolled angina or recent (<6 months) MI
- •- Another serious medical condition judged to compromise ability to tolerate neoadjuvant therapy and/or surgery
- •- Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk <5%
研究者
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