Phase II Study of Trimodality Therapy for Patients With Thymoma or Thymic Carcinoma at Significant Risk for Recurrence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- To determine the complete pathologic response rate to peroperative cisplatin and etoposide given concurrently with radiation in patients with thymoma thought to be at high risk for recurrence
研究概览
简要总结
This is a phase II study for patients with thymoma or thymic carcinoma thought to be at significant risk for recurrence following surgical removal. This study involves the use of combined chemotherapy and radiation therapy prior to surgery, in hopes of increasing the chances of complete resection. The chemoradiotherapy protocol is one which has been used extensively for other diseases, and the side effects are therefore well-documented. Patients with thymomas thought to be at significant risk for recurrence (by x-ray and pathology criteria) will be allowed to participate, and will undergo combined chemotherapy with radiation to the chest followed by surgical removal of the tumor and postoperative chemotherapy. The main outcome measured will be the rate of pathological complete response (e.g. no active tumor in the resected specimen) to the preoperative treatment. Patients will receive postoperative treatment based on surgical and pathologic criteria.
详细描述
Past experience has suggested that the ability to completely remove the thymoma using surgery is important in preventing recurrence. Strategies which would help the surgeon's ability to completely remove the tumor therefore need to be investigated.
This study represents a multi-institutional, phase II pilot trial of preoperative chemoradiotherapy followed by surgical resection and postoperative chemotherapy for patients with invasive thymoma or thymic carcinoma at significant risk for recurrence. We hypothesize that this strategy will be well-tolerated and produce response and resectability rates exceeding those previously published involving surgical resection alone, or preoperative chemotherapy followed by surgery. Patients with locally advanced thymoma, based on radiographic and biopsy criteria, will undergo pretreatment computed tomography (CT) scan and positron emission tomography (PET) followed by concurrent (simultaneous) chemotherapy (cisplatin and etoposide) and radiation. After this therapy, patients will be reassessed using computed tomography (CT) and PET, and undergo surgical resection of their tumors. Following resection, patients will be either observed, or treated with postoperative chemotherapy, or chemotherapy and radiation. Correlative genomic, serologic and pathologic studies will also be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven thymoma or thymic carcinoma.
- •Invasive thymoma determined by specific radiographic criteria determined by CT scan.
- •Acceptable kidney, liver, bone marrow, and respiratory functions.
- •Karnofsy performance status greater than 80%.
- •Patients must have a CT of the chest with IV contrast within 60 days of enrollment.
- •Tumors larger than 8cm in greatest diameter on CT scan.
- •For tumors 5-8cm in greatest diameter on CT scan, one or more of the following radiographic criteria must also be present on IV contrast CT Scan:
- •Multifocal calcification
- •Heterogeneous appearance
- •Irregular of scalloped borders
- •Obvious great vessel invasion or encirclement
排除标准
- •Considered unable to medically tolerate surgical resection at the time of initial presentation.
- •Radiographic evidence of stage IVA thymoma.
- •Pretreatment biopsy showing WHO type A thymoma unless obvious great vessel invasion/encirclement is present on CT scan.
- •Previous radiation therapy to the chest which would preclude the administration of radiation.
- •Patents receiving other investigational drugs.
研究组 & 干预措施
Registration
Cisplatin, Etoposide & concurrent radiotherapy
干预措施: cisplatin and etoposide (Drug)
Registration
Cisplatin, Etoposide & concurrent radiotherapy
干预措施: Concurrent Radiotherapy (Radiation)
Surgical Resection
No distant Progression post Registration Arm
干预措施: Surgical Resection (Procedure)
Post Resection
Assessment post surgical procedure to determine if at higher risk of recurrence or if complete resection could not be achieved.
干预措施: cisplatin and etoposide (Drug)
结局指标
主要结局
To determine the complete pathologic response rate to peroperative cisplatin and etoposide given concurrently with radiation in patients with thymoma thought to be at high risk for recurrence
时间窗: 16 weeks
次要结局
- Rate of complete resection following preoperative chemoradiotherapy as determined by pathologic examination of the specimen(s).(1-5 weeks)
- Toxicities throughout the study treatment.(5 years)
- Radiographic response to preoperative chemoradiotherapy by comparing pre and post treatment CT scans.(16 weeks)
- Blood-based correlative studies: genetic polymorphisms (EGFR, DNA repair, inflammatory gene pathways) and serologic analysis (EGFR, VEGF, bFGF, pro-MMP2 levels)(8-10 years)
- The role of PET in predicting resectability, Masaoka stage and histologic type, as well as the response to preoperative chemoradiotherapy by comparing pre and post treatment PET scans(10 years)
- Immunohistochemical assessment of relevant markers before and after chemoradiation (EGFR, p53,and Ki-67).(10-12 years)
- Recurrence rates and failure patterns following the treatment regimen.(5-7 years)