CTRI/2020/12/030115尚未招募3 期
: â??A Double Blind Randomized Controlled Trial of Renal Protective Effects of Normal Saline Plus Placebo Versus Normal Saline Plus Mannitol Prior to Cisplatin Containing Chemotherapy Regimens in Osteosarcoma and other Solid Tumorsâ??[CiNeMa]. - CiNeMa
The Terry Fox International Research0 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
- 尚未招募
- 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. Inclusion criteria
- •a)Patients with osteosarcoma and other solid tumors (lung, head and neck region and germ cell tumors) who are planned for Cisplatin at a minimum dose of 75 mg/m2
- •b)Patients aged 12- 70 years
- •c)Baseline GFR>= 60ml/min
- •d)ECOG performance status <= 2
排除标准
- •2.Exclusion Criteria
- •a)Patients undergoing treatment with nephrotoxic drugs (non-steroidal anti-inflammatory drugs, aminoglycosides, amphotericin B, or cephalosporins) or drugs that falsely elevate serum creatinine (sulfonamides) â?°
- •However, if patients received these drugs in the recent past after an appropriate washout period they can be enrolled which depends upon the half-life of the drugs. Details of drug specific wash out period as per:
- •Table No 1: Wash out period
- •Amphotericin Wash out period (4 weeks)
- •Aminoglycosides Wash out period (5 days)
- •Cyclophosphamide
- •Sulfonamides
- •DrugHalf life
- •Amphotericin15 day
- •NSAID2-60 hours
- •Aminoglycosides2-3 hours
- •Cyclophosphamide3-12 hours
- •Sulfonamide8-10 hours: normal patient
- •b.Patients having chronic renal disease with GFR < 60 ml/min Patients who suffer from severe suppression of bone marrow functionality, symptoms may be: extreme tiredness, easy bruising or bleeding, occurrence of infections
- •c.Patients having hearing impairment
- •d.Previous history of abdominal radiation
- •e.Patients receiving concurrent radiotherapy
- •f.Patients receiving concurrent experimental treatment
- •g. Fluid retention states like heart, liver or respiratory failure
- •h.High likelihood of tumor lysis syndrome
- •i.Presence of structural renal changes on ultrasonography esp. hydronephrosis
- •j.Pregnant or lactating females.
- •k.Patient with previous or current diagnosis of Hepatitis B virus (HBV), hepatitis C virus (HCV) (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening tests positive)â??.
- •l.Any other condition in view of PI/CO-I which might hamper patient safety.
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