CTRI/2018/11/016459尚未招募2 期
A randomized phase 2/3 trial of Rosuvastatin with neo-adjuvant chemo-radiation in patients with rectal cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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
入选标准
- •1.Age between 18 and 70 years
- •2.ECOG performance status 0 to 2
- •3.Histologic diagnosis of rectal adenocarcinoma
- •4.Clinical and radiological T3-4 N0 M0 or T (any) N + M0
- •5.Fit for receiving neoadjuvant chemoradiotherapy
- •6.Absence of colorectal synchronous Primary
排除标准
- •1.Patients with proven metastatic disease
- •2.History of Crohns disease or ulcerative colitis
- •3.Inherited polyposis syndromes
- •4.Ongoing statin or aspirin therapy for cardiovascular disease
- •5.Pregnant or nursing women
- •6.Patient not willing for informed consent
- •7.Comorbidities precluding statins and neo-adjuvant therapy including but not limited to Hepatitis, acute or chronic kidney disease
- •Hepatitis will be defined as sustained elevation of transaminases (two readings 5-7 days apart) >= 3 X upper limit of normal
- •Kidney disease will be defined as elevated creatinine levels above the upper limit of normal
- •8.Prior antineoplastic therapy
- •9.Patients already taking the following drugs: Cyclosporine, Gemfibrozil, Atazanavir/ritonavir, lopinavir/ritonavir, Tipranavir/ritonavir or simeprevir, Eltrombopag, Dronedarone, Itraconazole, Fluconazole or Ketoconazole, coumarin anticoagulants, lipid-lowering therapies: fibrates or lipid modifying doses (greater than or equal to 1 g/day) of niacin Aluminum and magnesium hydroxide combination antacid and Erythromycin
研究者
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