CTRI/2017/01/007626尚未招募未知
Comparison of conventional clinic follow up with clinician led video follow up in newly diagnosed patients with intermediate and high grade glioma undergoing adjuvant temozolomide therapy - SHADOW
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Participants must be post radical chemoradiation for a histologically confirmed newly diagnosed grade II-IV Glioma.
- •2.Participants must warrant adjuvant temozolomide
- •3.Age : Any age above 18 years. No maximum age.
- •4.Post first 2 cycles of adjuvant temozolomide
- •5.ECOG performance status <=2
- •6.Feasibility of doing video call at native place. Either internet based video call service or a smartphone based video call service. For internet based service either presence of skype or any other equivalent service for video call. For smartphone based video call presence of either a 3G or 4G service. For internet based video call presence of a webcam based camera of 480 pixels or more. For smartphone based video call presence of a front facing camera of 1.3 megapixels or more.
- •7.Participants must have normal organ and marrow function as defined below:
- •a.Leukocytes>=2,500/mcL or ANC >= 1000
- •b.Platelets>=100,000/mcL
- •c.Total bilirubin < 1.5 Ã? institutional upper limit of normal
- •d.AST(SGOT)/ALT(SGPT)<=2.5 Ã? institutional upper limit of normal
- •e.Calculated Creatinine clearance > 30 ml/min
- •8.The effect of temozolomide chemotherapy on the developing human fetus are teratogenic. Hence women and men of reproductive age must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. .
- •9.Both men and women of all races and ethnic groups are eligible for this trial.
- •10.Willing and able to comply with all study requirements, including treatment (able to swallow tablets), able to be followed up at regular intervals and/or nature of required assessments (e.g. ability to undergo video follow up)
- •11.Ability to understand and the willingness to sign a written informed consent document
排除标准
- •1.Participants who had life threatening complications either during CTRT with temozolomide or during first 2 cycles of temozolomide
- •2.Participants who are receiving any other investigational agents.
- •3.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
- •4.Uncontrolled intercurrent illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, inflammatory bowel disease, known hyperkalemia ( CTCAE version 4.02 grade 3 or above which is persistent over 1 week) or psychiatric illness/social situations that would limit compliance with study requirements.
- •5.Pregnant women and breastfeeding women are excluded from this study because temozolomide has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants. These potential risks may also apply to other agents used in this study.
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