MeDex: No Perioperative Dexamethasone in Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Dexamethasone Rescue Need
研究概览
简要总结
Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).
详细描述
This is a single-arm trial, assessing the safety and efficacy of brain metastasis resection without perioperative Dex in a maximum of 35 patients screened and enrolled in our emergency room and clinics. Investigators will assess efficacy by noting presence of absence of lymphopenia. The patients will be followed until initiation of postoperative adjuvant cancer therapy for collection of primary and secondary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New brain tumor(s) on imaging
- •Visceral mass(es) suspicious or confirmed for neoplasm
- •a. Patients with lung mass suspicious for primary lung cancer and no prior diagnosis must undergo biopsy of the lung mass prior to resection of brain metastasis(es) to exclude histology (i.e., small cell lung carcinoma) that would not benefit from resection
- •No contraindications for craniotomy
- •Age ≥ 18 years
- •ECOG performance status ≤ 2 (i.e., ambulatory > 50% of waking hours)
- •Midline shift on MRI ≤ 10 mm
- •Craniotomy planned to resect >75% of the enhancing mass (surgeon's judgment)
排除标准
- •Presence of BMs not eligible for resection that are each > 2 cm in any one dimension
- •>4 BMs not eligible for resection that are each 2 cm in any one dimension
- •Treatment with laser interstitial thermal therapy (LITT)
- •High concern for primary CNS lymphoma
- •Diagnosis of small cell lung carcinoma
- •Any receipt of Dex
- •Steroid use in the past month
- •A condition that requires steroids
- •Stage 4 chronic kidney disease (GFR<30)
- •Pregnant or breastfeeding
研究组 & 干预措施
Withholding perioperative dexamethasone
The safety and feasibility of withholding perioperative dexamethasone (Dex) in newly diagnosed cancer patients undergoing resection of brain metastases (BMs). The primary question is not comparative efficacy, but rather whether it is safe to forgo Dex in this patient population.
干预措施: Withholding perioperative Dexamethasone (Other)
结局指标
主要结局
Dexamethasone Rescue Need
时间窗: 4 weeks post operative (+-) 2 weeks
Initiation of dexamethasone after enrollment up to 3 weeks after surgery.
Dexamethasone Rescue Need
时间窗: 4 weeks post operative (+-) 2 weeks
Initiation of dexamethasone after enrollment up to 3 weeks after surgery.
次要结局
- Immunosuppression Assessment(4 weeks post operative (+-) 2 weeks)
- Immunosuppression Assessment(4 weeks post operative (+-) 2 weeks)
研究者
Akshitkumar MIstry
M.D., Assistant Professor
University of Louisville