A Novel Target Delineation Scheme Based on RTOG(Radiation Therapy Oncology Group) and EORTC(European Organisation for Research and Treatment of Cancer) Guidelines Impact on Survival Time and Radiotherapy Complications in High-grade Glioma Patients: a Single-center Randomized Single-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
The main question it aims to answer are:
- whether the new target delineation scheme can improve Progression-free Survival
- whether it can reduce the incidence of radiation complications in high-grade glioma patients.
Participants in trial group will be performed radiotherapy of new target delineation method after the completion of the operation within 4-6 weeks., while participants in the control group be performed radiotherapy of EORTC(European organisation for research and treatment of cancer) target delineation method.Temozolomide 75 mg / ( m² · d ) will be given to both groups of patients during radiotherapy. After radiotherapy, its dose changes to 150 ~ 200 mg / ( m² · d ) for 5 days and stopped for 23 days as a cycle. There are 6 cycles in total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High-grade glioma (2021 WHO grade III or IV)
- •Age between 18-65 years old, Karnofsky performance status (KPS) score ≥ 70
- •result of pregnancy test being negative within 7 days before enrollment, only applicable to women with reproductive potential
- •The patient voluntarily joined this study and signed an informed consent form
- •Willing to return for follow-up
- •Willing to provide tissue and blood samples for this research
- •Surgical treatment was completed without any postoperative complications (such as consciousness disorders, hematomas, lung infection and cardiac insufficiency)
- •Radiotherapy within 4-6 weeks after surgery
- •No contraindications for taking temozolomide
排除标准
- •Low-grade glioma(2021 WHO grade I or II)
- •had or having other type of malignant cancers
- •not having been performed gross total resection of tumor
- •Severe active comorbidities, systemic diseases or other serious comorbidities that would render the patient unsuitable for participation in this study or seriously interfere with the appropriate evaluation of the safety and toxicity of the prescribed regimen in the judgment of the investigator, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, or mental illness；
- •Baseline MRI indicates a previous or recent risk of cerebral hemorrhage or hernia;
- •Pregnancy or lactation, or pregnancy or childbirth during the expected trial period(from pre-screening or screening visits until 120 days after the last trial treatment)
- •Unable to perform brain magnetic resonance imaging;
- •Allergic to CT contrast agent, unable to perform enhanced CT examination;
- •Remote transfer;
- •Medical contraindications for receiving radiation therapy, such as active systemic lupus or scleroderma
研究组 & 干预措施
reduced CTV (clinical target volume) and PTV (planning target volume)
干预措施: reduced target volume (Radiation)
EORTC CTV (clinical target volume) and PTV (planning target volume)
干预措施: EORTC (European organisation for research and treatment of cancer) target volume (Radiation)
结局指标
主要结局
progression-free survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
confirm if the participant's cancer progresses or he/she dies every time back to the hospital during screening and follow-up
次要结局
- overall survival(From date of randomization until the date of death from any cause, assessed up to 3 year)
- European organisation for research and treatment of cancer QLQ-C30 (EORTC-QLQ-C30)(through study completion, up to 3 years)
- radiotherapy complication incidence(through study completion, up to 3 years)