CTRI/2017/08/009265招募中3 期
A Phase III randomized clinical trial to study the radiosensitizing effect of Nelfinavir in Advanced Carcinoma of Cervix. - NELCER
Tata Memorial Centre and Varian International0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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.ECOG 0-2.
- •2.FIGO 2018 Stage IIIA (TNM stage T3a N0 M0)
- •FIGO 2018 Stage IIIB (TNM stage T3b N0 M0)
- •FIGO 2018 Stage IIIC (TNM stage Any T N1 M0)
- •3.No previous irradiation to the pelvis or chemo therapy
- •4.Ability to tolerate full course of pelvic radiotherapy and brachytherapy
- •5.Adequate bone marrow, liver, and kidney function defined as neutrophil count ââ?°Â¥ 1500, platelet count ââ?°Â¥ 100,000, total bilirubin < 1.5 x upper limit of normal (ULN), AST and ALT ââ?°Â¤ 2.5 x ULN, and creatinine < 1.5 upper limit of normal OR Creatinine clearance > 60 mL/min/1.73 m2
- •6.No recent ( < 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
- •7.Ability to understand and the willingness to sign an informed consent document.
- •8.Should be willing to undergo extra biopsy and blood collection for pharmacokinetic studies.
排除标准
- •1.Patients with newly diagnosed diabetes. uncontrolled DM that is patients with Hb1c of greater than 6.5% of FBS value or BFS greater than or equal to 126mg/dL respectively on primary evaluation
- •2.Patients on any drugs which has pharmacological interaction with nelfinavir:
- •-Terfenadine, cisapride, sildenafil, lovastatin or simvastatin and medication that are metabolized by the CYP3A4 isoenzyme.
- •-Antiarrhythmics (amiodarone, quinidine).
- •-Neuroleptics (pimozide).
- •-Sedative/Hypnotic agents (midazolam, triazolam).
- •-Ergot derivatives.
- •-HMG-CoA reductase inhibitors (atorvastatin).
- •-Rifampicin, Rifabutin.
- •-Felodipine, Nifedipine.
- •3.Pregnant or lactating
- •4.Active co existing malignancy.
- •5.HIV positive patients will be excluded.
- •6.Patients with hemophilia.
- •7.Patients with reduced creatinine clearance ( less than 50 ml/ min) or unilateral or bilateral hydronephrosis will be excluded.
- •8.History of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
研究者
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