NCT05354570招募中2 期
Phase II Study of Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Patients With Pleural Metastases From Thymic Malignancies
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 13
- 主要终点
- assess the rate of radiation pneumonitis
研究概览
简要总结
The researchers are doing this study to find out whether hemithoracic intensity-modulated pleural radiation therapy (IMPRINT) is a safe treatment that causes few or mild side effects in people with pleural metastases from thymic malignancies. The researchers will also look at whether hemithoracic IMPRINT is effective against participants' cancer.
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent to participate on the study
- •Patients must have a pathologically confirmed diagnosis of thymic malignancy. Thymic carcinoma is allowed.
- •Patients must have radiologic or pathologic evidence of pleural metastases. Patients may have de novo stage IVA or recurrent disease in the pleura. Gross disease in the fissure is allowed if resected.
- •No evidence of extrathoracic metastatic disease or contralateral pleural/pericardial disease.
- •Patient age ≥ 18 years but ≤ 80 years at the time of consent
- •Karnofsky performance status ≥ 80%
- •Preoperative or Postoperative Pulmonary Function Tests: DLCO > 40% predicted (corrected for Hgb) and FEV1 ≥ 35% (corrected for Hgb)
- •Glomerular filtration rate (GFR): ≥50 mL/min/1.73 m2 (must be calculated using estimated creatinine clearance (CrCl) by the Cockcroft-Gault (C-G) equation (Nephron 1976;16:31-41): CrCl (mL/min) = [140 - age (years)] x weight (kg) [x 0.85 for female patients] 72 x serum creatinine (mg / dL) ° In cases of concern about decreased renal function and potential high radiation dose to the kidneys, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney.
排除标准
- •Continuous oxygen use
- •Patients with an acute flare of myasthenia gravis requiring addition of new medication in the past 6 months
- •Prior nephrectomy on the contralateral side of the pleural metastases
- •Prior thoracic radiation therapy preventing hemithoracic pleural IMRT. Prior thymic bed radiation is allowed. Prior pleural SBRT is allowed.
- •Patients undergoing extrapleural pneumonectomy. Other surgical resection approaches of the pleural nodules (ex: P/D, debulking/metastasectomy) are allowed. Surgical resection of the primary thymic tumor is allowed.
- •Acute congestive heart failure requiring hospitalization within the past 30 days.
- •COPD requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are allowed
- •Unstable angina requiring hospitalization and/or transmural myocardial infarction within the last 3 months
- •History of interstitial lung disease
- •Pregnant or lactating women
- •Men or women not using effective contraception
研究组 & 干预措施
Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT)
Experimental
Radiation will be administered over approximately 6 weeks to 50.4 Gy in 28 fractions with an optional SIB to gross residual disease.
干预措施: Intensity-Modulated Pleural Radiation Therapy (IMPRINT) (Radiation)
结局指标
主要结局
assess the rate of radiation pneumonitis
时间窗: 2 years
as indicated by the rate of grade 3 or higher radiation pneumonitis defined by the NCI Common Terminology Criteria (CTC) version 5.0.
次要结局
- progression-free survival (PFS)(12 month)
研究者
研究点 (13)
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