CTRI/2018/07/015056招募中3 期
TOP : Adult diffuse lower grade gliomas : Temozolomide Or PCV as adjuvant therapy. - TOP
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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.Participants must have grade 2 glioma or grade 3 glioma as per WHO 2016 classification, post maximal safe resection with high risk features for recurrence.
- •2.ECOG performance status <=2
- •3.Participants must have normal organ and marrow function
- •4.The effects of TMZ and PCV on the developing human fetus are teratogenic. Hence women of childbearing potential and men 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. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of protocol.
- •5.Both men and women of all races and ethnic groups are eligible for this trial.
- •6.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)
- •7.Ability to understand and the willingness to sign a written informed consent document
排除标准
- •1.Pilocytic or pilocytic like glioma or glioblastoma will be excluded as their histology can be confused with IDH negative Grade 2 glioma. All IDH wild type gliomas will be discussed in JNOM and if features suggest one of these 3 histologies, they will then be excluded. IDH wild type grade 2-3 glioma will be included in the study. IDH mutation will be defined as presence of cytoplasmic positivity with IDH IHC and/or detection of mutation at IDH1R132 or IDH2 R172 locus on sequencing.
- •2.Patients who on radiology have features suggestive of glioblastoma or impending GBM will be excluded. This decision will be taken in JNOM.
- •3.Participants who are receiving any other investigational agents.
- •4.Patients with QTc prolongation defined as QTc interval greater than 440 ms in males and 480 ms in females in view of risk of sudden cardiac death associated with use of Ondansetron.
- •5.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
- •6.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.
- •7.Pregnant women and breastfeeding women are excluded from this study because temozolomide has the potential for teratogenic or abortifacient effects and 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. in this situation. In keeping with ICH E8, the pregnancy of a female subject will be reported to the IRB/EC. The female subject will receive counseling about the risks to the fetus and would be given a option of termination of pregnancy . If the female subject chooses to continue the pregnancy, then the investigator would follow her pregnancy to term (or longer if possible for developmental sequelae), so that any important safety information could be obtained.
- •8.Patients with human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive; or with a history of chronic active hepatitis or cirrhosis. The testing for the same will be done in accordance with institutional standards with accompanying pre and post test counselling according to the institutional standards.
- •9.Patients with a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product administration or may interfere with the interpretation of the results
研究者
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