Phase II Pilot Randomized Controlled Trial to Assess Feasibility of "Supra-marginal" Surgical Resection of Malignant Glioma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Enrollment
研究概览
简要总结
G-SUMIT is a pilot, phase II,randomized controlled trial to evaluate the feasibility of performing a large-scale trial in patients undergoing surgery for first-time diagnosis of high grade glioma (HGG) in a surgically favorable anatomical location to answer the following:
Does extending the margin of resection 1 cm beyond visible enhanced volume on MRI result in (a) an increase in overall survival? (b) result in a similar rate of "clinically-significant" neurological worsening during 30 days post surgery and quality of life at 6 and 12 months?
详细描述
This pilot, multi-centre, pragmatic randomized controlled trial is planned to simulate all aspects of a larger definitive trial comparing conventional versus supramarginal tumor resection at the time of the first surgical resection of HGG in appropriately selected patients. This pilot will help determine the ability to meet pre-specified criteria in identification, recruitment, and patient allocation, allow for refinement of eligibility criteria for optimal recruitment, confirm safety of procedure and ability to retain participants for the duration of the trial. Preliminary efficacy data will inform sample size calculations and estimation of resources required for the envisioned larger definitive trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG;
- •Age ≥18 ≤ 85 years;
- •Karnofsky Performance Score ≥ 60;
- •Location of tumor in a safe anatomical location and
- •Patient or substitute decision maker (SDM) able to understand and consent to study participation.
排除标准
- •Multi-focal tumor, gliomatosis cerebri (≥3 lobes of the brain affected), tumors crossing the midline, or leptomeningeal enhancement;
- •Previous craniotomy for tumor excision (stereotactic biopsy is permitted);
- •Known metastatic cancer;
- •Uncorrectable coagulopathy;
- •Unable to obtain GAD-enhanced brain MRI.
研究组 & 干预措施
Supramarginal resection (intervention arm)
Planned resection beyond the Gadolinium (GAD)-enhancing region extending to either at least 1 cm into non-enhancing tissue, or the nearest non-enhancing sulcal boundary/ventricle wall if these structures are closer than 1 cm.
干预措施: Supramarginal resection (Procedure)
Conventional (i.e. GTR) resection
Planned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin.
干预措施: Conventional (i.e. GTR) resection (Procedure)
结局指标
主要结局
Enrollment
时间窗: Collected at time of randomization, through end of enrollment period (2 years)
The number of patients enrolled and successfully allocated to the intervention versus the control treatment
次要结局
- Feasibility using Gross Total Resection(2 days (+/- 1 day) post surgery)
- Feasibility using proportion of consent(Screening/Enrollment)
- Efficacy using progression-free survival(6 weeks (+/- 2 weeks), 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery)
- Safety using global disability(6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery)
- Feasibility using number of completed visits(Through study completion, on average 2 years)
- Safety using neurological function(2 (+/- 1) days and 6 weeks (+/- 2 weeks), days post surgery)
- Safety using 6 weeks (+/- 2 weeks) all cause-mortality(6 weeks (+/- 2 weeks) post surgery)
- Radiological(2 (+/- 1) days, 6 months (+/- 2 weeks) and 12 (+/- 1) months)
- Feasibility using eligibility(Screening/Enrollment)
- Efficacy using overall survival(6 weeks (+/- 2 weeks), 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery)
- Safety using quality of life(6 months (+/- 2 weeks) and 12 (+/- 4 weeks) post surgery, 24 (+/- 4 weeks) post surgery)