A Phase II Metastasectomy Study for Patients With Renal Cell Carcinoma
概览
- 阶段
- 2 期
- 干预措施
- Follow-Up Care
- 疾病 / 适应症
- Renal Cell Carcinoma
- 发起方
- M.D. Anderson Cancer Center
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Binary indicator that the patient is alive with no evidence of disease progression (either progression or relapse) post surgery
- 状态
- 进行中（未招募）
- 最后更新
- 17天前
概览
简要总结
This phase II trial studies the follow-up after metastasectomy in patients with kidney cancer. Following up patients' health condition after metastasectomy may help doctors to learn if the surgical removal of the primary tumor or the parts of the cancer that has spread to other parts of the body is a good method for treating patients who have kidney cancer.
详细描述
PRIMARY OBJECTIVES: I. To assess the 24-week progression free/relapse free survival rate in patients undergoing metastasectomy for metastatic renal cell carcinoma (mRCC). SECONDARY OBJECTIVES: I. To evaluate progression free survival (PFS), relapse free survival (RFS) and overall survival (OS) in patients undergoing metastasectomy. II. To evaluate tissue determinants predictive for resectability, PFS and OS in patients undergoing metastasectomy. OUTLINE: After metastasectomy, patients are followed up every 6 months for up to 5 years.
研究者
入排标准
入选标准
- •Patients with histologically or cytologically confirmed renal cell carcinoma (RCC)
- •Patients have clinical reasons for undergoing a surgical resection of tumor; there are two main categories of patients:
- •Patients with fully resectable disease as defined by lesions accessible by a surgeon during no more than two separate surgical sessions, and are expected to be rendered surgically no evidence of disease (NED)
- •Patients undergoing a noncurative procedure for relief of symptoms or for management of threatening lesions
- •Patients have been deemed resectable by the subspecialty surgeon involved in the patient's care
- •Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy; the only approved consent is attached to this protocol
- •Patients must have ability to comply with study and/or follow-up procedures
- •Members of all races and ethnic groups are eligible for this trial
排除标准
- •Patients must not have active acute infections that could be worsened by surgery or interfere with this study
- •Patients must not have clinically significant cardiovascular disease, or peripheral vascular disease that creates an unacceptably high operative risk
- •Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates surgical resection, or render the subject at high risk from treatment complications
- •Patients must not have a history of uncontrolled severe depression
研究组 & 干预措施
Observational (follow-up)
After metastasectomy, patients are followed up every 6 months for up to 5 years.
干预措施: Follow-Up Care
Observational (follow-up)
After metastasectomy, patients are followed up every 6 months for up to 5 years.
干预措施: Laboratory Biomarker Analysis
结局指标
主要结局
Binary indicator that the patient is alive with no evidence of disease progression (either progression or relapse) post surgery
时间窗: 24 weeks
Assessed using a logistic regression model.
次要结局
- Progression free survival (PFS)(Up to 5 years)
- Disease free survival (DFS)(Up to 5 years)
- Overall survival (OS)(Up to 5 years)