A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (Alimta) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Pathological Complete Response
研究概览
简要总结
This study aims to determine how successful the chemotherapy regimen of Pemetrexed plus cisplatin before surgery is at killing all the tumor so that none is left at the time of surgery. Following surgery, all eligible patients will receive radiation to the chest. How patients respond, whether the cancer returns and if so, where, will also be monitored.
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
- •Patients will be clinically staged using AJCC/UICC TNM staging criteria. Eligible stages:
- •Patients must be M0
- •Patients with T1, T2, and T3 disease (without cardiac involvement) are eligible (T status can be established clinically and radiologically or at exploratory thoracotomy without surgical resection
- •Patients with N0, N1,or N2 disease are eligible
- •Performance status of 0 to 1 on the ECOG performance status schedule.
- •No prior systemic chemotherapy and no prior intracavitary cytotoxic drugs or immunomodulators, unless given for the purpose of chemical pleurodesis
- •No previous radiation therapy
- •Estimated life expectancy of at least 12 weeks
排除标准
- •Patients will be excluded if they meet ANY of the following criteria:
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- •Have previously completed or withdrawn from this study or any other study investigating pemetrexed
- •Pregnancy or breast-feeding
- •Serious concomitant systemic disorders (i.e. active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
- •Second active primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous carcinoma of the skin, low grade (Gleason score less than or equal to 6), localized adenocarcinoma of the prostate or other malignancy treated at least 2 years previously with no evidence of recurrence
研究组 & 干预措施
A
chemotherapy, surgery then chest radiation x 54 gray (Gy)
干预措施: pemetrexed (Drug)
A
chemotherapy, surgery then chest radiation x 54 gray (Gy)
干预措施: cisplatin (Drug)
结局指标
主要结局
Pathological Complete Response
时间窗: Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)
Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy \[EPP\]). Resected tissue or pleural fluid should be sent for pathological and histological evaluation.
次要结局
- The 1 and 2 Year Disease-Free Survival Rate (Percentage)(1 year and 2 years)
- Overall Tumor Response(baseline to measured progressive disease)
- Time to Treatment Failure(baseline to stopping treatment)
- Time to Progressive Disease(baseline to measured progressive disease)
- Overall Survival Time(baseline to date of death from any cause)