Randomized Phase II Study of Pre-operative Chemoradiotherapy +/- Panitumumab (IND #110152) Followed by Consolidation Chemotherapy in Potentially Operable Locally Advanced (Stage IIIA, N2+) Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 31
- 主要终点
- Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab.
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy (CT), such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy (RT) uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without panitumumab in treating patients with non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying chemotherapy and radiation therapy to see how well they work when given with or without panitumumab in treating patients with stage IIIA non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the mediastinal nodal clearance after completion of induction chemoradiotherapy with or without panitumumab in patients with stage IIIA non-small cell lung cancer.
Secondary
- Assess overall survival of these patients.
- Evaluate patterns of first failure in these patients.
- Determine the acute and late adverse events associated with these regimens.
- Assess surgical morbidities in patients with resectable disease at reassessment.
- Determine the correlation between pre- and post-treatment biomarkers (including epidermal growth factor receptor (EGFR) and ras mutation status) and outcomes (mediastinal nodal clearance and overall survival).
- Evaluate the prognostic value of plasma osteopontin and microRNA for overall survival.
- Assess the ability of FDG-PET/CT scan re-staging to predict outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Induction CT+RT
Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
干预措施: surgery (Procedure)
Induction CT+RT
Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
干预措施: carboplatin (Drug)
Induction CT+RT
Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
干预措施: paclitaxel (Drug)
Induction CT+RT+Panitumumab
Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
干预措施: panitumumab (Drug)
Induction CT+RT+Panitumumab
Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
干预措施: carboplatin (Drug)
Induction CT+RT+Panitumumab
Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
干预措施: paclitaxel (Drug)
Induction CT+RT+Panitumumab
Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
干预措施: surgery (Procedure)
结局指标
主要结局
Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab.
时间窗: From date of randomization to time of protocol surgery, approximately 12 weeks.
The assessment of whether mediastinal nodes which were involved at the time of study registration were clear of disease following induction chemoradiotherapy with or without panitumumab; the assessment is made at the time of surgery 4-6 weeks after chemoradiation. If surgery could not be performed, the patient was considered as not having had mediastinal nodal clearance.
次要结局
- Surgical Morbidities in Patients With Resectable Disease at Reassessment(From date of surgery to 30 days following surgery.)
- Response Rate(From date of randomization to time of protocol surgery, approximately 12 weeks.)
- Overall Survival(Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study)
- Patterns of First Failure(Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.)
- Percentage of Patients With Grade 3 or Higher Acute and Late Adverse Events(Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.)
- Ability of FDG-PET/CT Scan Data to Predict Outcome(Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.)