Daily Temozolomide for Elderly Patients With Unmethylated MGMT- Promoter Newly Diagnosed GliOblatoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Glioblastoma is an aggressive type of brain cancer. Standard treatment usually includes three weeks of radiation therapy alone or combined with chemotherapy using Temozolomide. After a four- to six-week break, more Temozolomide chemotherapy is usually given. However, some tumors have a marker ("unmethylated MGMT") that predicts the usual chemotherapy won't work. Because of this, this project will explore other treatment options to help slow the disease and improve survival. In this study, the same chemotherapy (Temozolomide) normally given after radiation therapy for glioblastoma. The only difference is that it will be given with a modified regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years.
- •Histopathologically confirmed newly diagnosed WHO grade 4, IDH wild-type GBM
- •Unmethylated MGMT promoter, according to local assessment
- •Completed treatment with 40 Gy in 15 fractions over three weeks, with concurrent TMZ, within six weeks prior to enrollment
- •Eastern Cooperative Oncology Group (ECOG) performance status scale of 0, 1, or
- •Karnofsky Performance Status (KPS) ≥
- •Adequate organ function, as defined by the following laboratory values obtained within 28 days prior to enrollment:
- •Absolute neutrophil count (ANC) >1.5 × 10⁹/L (1,500 cells/mm³).
- •Platelet count >100 × 10⁹/L (100,000 cells/mm³).
- •Serum creatinine <1.5 times the upper limit of normal.
- •Total serum bilirubin <1.5 times the upper limit of normal.
- •ALT (SGPT) <2.5 times the upper limit of normal and/or AST (SGOT) <2.5 times the upper limit of normal.
- •Signed informed consent (and assent, if applicable) must be obtained from the participant or their legal representative, ensuring the participant's ability to adhere to the study requirements.
排除标准
- •Diffuse leptomeningeal involvement at the time of diagnosis.
- •Inability to undergo contrast-enhanced magnetic resonance imaging (MRI)
- •Known hypersensitivity to TMZ components or Dacarbazine
- •Severe myelosuppression
- •Active hepatitis B infection
- •Severe or uncontrolled medical conditions (e.g., active systemic infection, diabetes, hypertension, coronary artery disease, or psychiatric disorders) that, in the investigator's judgment, could compromise patient safety or impede study completion.
- •History of prior or second invasive malignancy, except for:
- •Non-melanoma skin cancer.
- •Completely resected cervical carcinoma in situ.
- •Low risk prostate cancer or under active surveillance.
- •Other cancers for which the subject has completed potentially curative treatment more than 3 years prior to study entry are allowed.
研究组 & 干预措施
Treatment
Daily TMZ
干预措施: Daily TMZ (Drug)
结局指标
主要结局
Overall survival
时间窗: From initial diagnosis until date of death from any cause (assessed up to 24 months)
How long the participant survives following initial diagnosis
次要结局
- Progression-free survival(From initial diagnosis until disease progression (assessed up to 24 months))
- Toxicities(From treatment start through study completion (estimated up to 5 years))