A phase II randomized controlled study comparing post-operative stereotactic radiotherapy versus conventional radiotherapy along with concurrent and adjuvant temozolomide in patients with de novo glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess and compare the median
研究概览
简要总结
Glioblastoma is one of the most aggressive malignancies of the central nervous system with a median survival of only 14.6 months even after standard-of-care treatment, which is maximal safe resection followed by adjuvant radiotherapy with concurrent and adjuvant temozolomide. A dose of 60Gy in
30 fractions delivered over 6 weeks is the conventional standard dose regimen for adjuvant radiotherapy in glioblastoma The most common pattern of recurrence is local relapse and almost 85-90% of relapses occur in the radiation field or high-dose areas, suggesting a role for dose escalation.
Stereotactic radiotherapy, if found effective and safe would provide a novel method to escalate the dose delivered to the post-op bed with better sparing of surrounding critical structures. SRT also reduces the overall treatment time which might lead to better local control and decrease the patient load in high-volume centers. The present study has been designed to assess the survival and toxicity profile of hypo fractionated stereotactic radiotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with histopathological confirmed diagnosis of GBM Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 Absence of uncontrolled medical comorbidity Normal organ function (Hb;10 g/dL, platelet count >;1 lakh/cu mm, creatinine clearance > 60 mL/sec, AST/ALT ≤ 3 times the upper limit of the normal range, serum bilirubin ≤ upper limit of the normal range).
排除标准
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 3-4 Recurrent GBM Any previous history of cancer treatment including surgery, radiation, or chemotherapy Psychiatric condition or neurological co-morbidities with major cognitive function disorder Any uncontrolled comorbidity that may compromise the delivery of protocol-defined chemotherapy and radiotherapy e.g., renal disease, cardio-respiratory disease, diabetes mellitus Contraindications for CT/MRI imaging or contrast injection.
结局指标
主要结局
To assess and compare the median
时间窗: 1 year
overall survival between the experimental and conventional arm at 1 year
时间窗: 1 year
次要结局
- To assess and compare the incidence(of grade 2 or worse acute toxicity)
- To assess the treatment response(rate after treatment completion in two)
- To compare the progression-free(survival in the 2 arms.)
- To compare the quality of life in the(two arms)
- To assess and compare the caregiver(burden related to patients)
- To assess and compare the impact(on cognition in two treatment arms.)
研究者
Dr Anjali V R
All India Institute of Medical Sciences