Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer
Dose-Dense Induction/Neoadjuvant Chemotherapy in the Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer With Additional Genomic Analyses to Identify Signatures Predictive of Chemotherapy Response.
研究概览
详细说明
All patients will receive induction chemotherapy with cisplatin and docetaxel. Pegfilgrastim will be administered approximately 24 hours following the end of the day 1 chemotherapy infusion. Cycles will be repeated every 2 weeks for 3 cycles. Patients deemed to be resectable will undergo surgical resection followed by postoperative thoracic radiotherapy. Patients deemed inoperable will additionally receive concurrent chemoradiotherapy. Response, using radiographic and/or pathologic means, will identify two cohorts; responders and nonresponders.Gene expression profiling will then be performed on pre-treatment specimens to identify signatures that predict for chemotherapy sensitivity or resistance.
The target enrollment is 45 patients.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with documented stage III NSCLC (IIIA or IIIB, without malignant pleural/pericardial effusion) are eligible for enrollment if they are considered appropriate for treatment with chemotherapy, radiation, or surgery;
- IIIA: T1-3 N2 M0, T3 N1 M0
- IIIB: T4 N0-2 M0, T 1-4 N3 M0
- Measurable or evaluable disease
- Previously untreated with chemotherapy or radiotherapy for lung cancer;
- No brain metastases;
- No prior XRT
- Performance status 0-2
- ≥18 years of age
- Informed Consent
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Bilirubin ≤ 1.5 x upper limit of normal for the institution (ULN)
- SGOT and SGPT ≤ 2.5 x ULN for the institution
- Creatinine ≤ 1.6 mg/dL
- Hemoglobin ≥ 8.0 g/dL
- Peripheral neuropathy ≤ grade 1
Exclusion Criteria:
- Known sensitivity to E. coli derived products (e.g. Filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® Growth Hormone, INTRON® A);
- Use of IV systemic antibiotics within 72 hours prior to chemotherapy;
- Known HIV infection
- Lithium or cytokines within 2 weeks prior of entry
- Additional concurrent investigational drugs
- History of myelodysplastic syndrome
- Pregnant, nursing or having unprotected sex
- Not available for follow-up assessment
- Unable to comply with protocol procedures
- Illnesses that may compromise ability to give informed consent.
- Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Induction Chemotherapy
Cisplatin 75mg/m2 IV days 1, 15, 29; Docetaxel 75mg/m2 IV days 1, 15, 29; and Pegfilgrastim 6mg SC day 2, 16, 30
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其他名称:
其他名称:
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Induction Response
大体时间:Between 2 and 3 weeks after induction
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Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.
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Between 2 and 3 weeks after induction
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Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy
大体时间:at the end of the study, estimated 2.5 years
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at the end of the study, estimated 2.5 years
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次要结果测量
结果测量 |
大体时间 |
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Number of Grade III/IV Hematologic Adverse Events
大体时间:During induction chemotherapy, approximately 6 weeks
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During induction chemotherapy, approximately 6 weeks
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Number of Grade III/IV Non-hematologic Adverse Events
大体时间:During induction chemotherapy, approximately 6 weeks
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During induction chemotherapy, approximately 6 weeks
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Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction
大体时间:During induction, approximately 6 weeks
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During induction, approximately 6 weeks
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Overall Survival
大体时间:Approximately 10 years
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Approximately 10 years
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合作者和调查者
合作者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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