ISRCTN46692480已完成不适用
Systemic chemotherapy and the liver-first approach compared to index colorectal resection for colorectal cancer presenting with synchronous liver metastases: a randomised controlled trial (the RVERS trial)
Central Manchester University Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 120 人开始时间: 2012年10月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •In order to be eligible for inclusion, patients must fulfil the following criteria:
- •1. Over 18 years of age
- •2. Able to give informed consent
- •3. Have a histological diagnosis of colorectal cancer
- •4. No prior history of malignancy
- •5. Have radiological evidence on either contrast-enhanced computed tomography or contrast-enhanced magnetic resonance scanning of hepatic metastases at the time of diagnosis of the primary tumour or within 3 months thereof. (Liver metastases should not be biopsied)
- •6. Liver metastatic burden feasible for surgical resection as agreed by an appropriately constituted multi-disciplinary team or to be downstageable for resection by neoadjuvant chemotherapy
- •7. Computed tomographic and/or 18fluoro-deoxyglucose positron emission tomographic (FDG-PET) of the absence of pulmonary metastases
- •8. Magnetic resonance scan assessment of rectal primary tumours
- •9. World Health Organisation performance status (PS) 0, 1 or 2 (see Appendix 2) and considered by both multidisciplinary team and a specialist oncologist to be suitable for chemotherapy.
- •10. Baseline laboratory tests (within 1 week prior to randomisation):
- •neutrophils ¡Ý 1.5 x109/l and platelet count ¡Ý 100 x109/serum bilirubin ¡Ü 1.25 x upper limit of normal (ULN), alkaline phosphatase ¡Ü 5 x ULN and serum transaminase (either AST or ALT) ¡Ü 2.5 x ULN, estimated creatinine clearance (Cockcroft; appendix VIII) >50ml/min or measured GFR (EDTA clearance) >50 ml/min
- •11. For women of childbearing potential, negative pregnancy test and adequate contraceptive. Adequate contraception for men.
- •12. Consent to allow surplus pathological material to be analysed for translational research projects (patients may decline participation in this supplementary component and still participate in the main trial).
排除标准
- •1. Patients who are under 18 years of age
- •2. Patients who are unable to give informed consent
- •3. Patients who are unfit for the chemotherapy regimens in this protocol, for example: severe uncontrolled concurrent medical illness (including poorly-controlled angina or very recent myocardial infarction, i.e. in previous 3 months) likely to interfere with protocol treatments
- •4. Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication
- •5. Partial or complete bowel obstruction not amenable to resolution by stent or diversion
- •6. Pre-existing neuropathy (> grade 1)
- •7. Patients requiring on-going treatment with a contraindicated concomitant medication
- •8. Patients with another previous or current malignant disease
- •9. Patients with known hypersensitivity reactions to any of the components of the study treatments
- •10. Patients with brain metastases
- •11. Female patients who are lactating
- •12. Patients who have received prior chemotherapy with oxaliplatin
- •13. Patients with a personal or family history suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency or with known DPD deficiency
研究者
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