NCT00903942撤回2 期
A Modified Two Stage Phase II Study of Combination Abraxane and Radiation for Stage III Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- To assess feasibility of one cycle induction chemotherapy of Abraxane plus Carboplatin followed by low-dose sensitizing Abraxane and radiation followed by consolidation Abraxane and carboplatin for stage III NSCLC.
研究概览
简要总结
For patients with stage III Lung Cancer, We propose one cycle chemotherapy using Abraxane and Carboplatin, followed by pulsed low-dose sensitizing Abraxane chemotherapy and daily Radiation. This will be followed by more hi-dose chemotherapy. We anticipate this regimen to target early distant microscopic spread by using one cycle of chemotherapy prior to radiation, and to achieve control of the disease in the lung by combining pulsed low-dose sensitizing Abraxane, with radiation.
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
- •Histologically confirmed NSCLC.
- •Clinical or pathologic stage IIIA (T1-3N2M0, T3N1M0) and IIIB (Any T N3M0, T4 Any N M0) diseases according to the American Joint Committee of Cancer criteria.
- •Patients with malignant pleural effusion will be excluded.
- •The primary tumor must be radiographically measurable.
- •Karnofsky performance status > 70 or Zubrod PS 0 or
- •FEV1 sufficient for patients to tolerate radiation therapy, which is at the discretion of the radiation oncologist, usually > 800 ml, but may be higher or lower depending on the volume of radiotherapy portal, which is a variable of the tumor extent.
- •WBC > 3000; platelet count > 100,000; absolute neutrophil counts > 1,500; HGB > 9.0 g/dl, serum creatinine < 1.5 mg/dl or creatinine clearance > 60 ml/min. Laboratory values must be obtained < 4 weeks prior to registration.
- •Patients with equivocal enlargement of adrenal gland(s) on CT scan, or a few equivocal regional or distant lesions on any imaging studies need further imaging study (PET, bone scan, or others) or biopsy to rule out distant metastasis.
- •Patients must have adequate liver functions: AST and ALT < 2.5 x upper limit of normal, alkaline phosphatase < 2.5 x upper limit of normal, unless bone metastasis is present in the absence of liver metastasis. Bilirubin <1.5 mg/dL.
- •Pre-existing neuropathy must not be worse than grade I.
- •A signed informed consent.
- •Normal organ function including EKG findings deemed acceptable for chemotherapy by the medical oncologist.
排除标准
- •Patients with distant metastasis (stage IV disease).
- •Patients without measurable disease.
- •Patients with medical contraindication to chemotherapy or radiotherapy.
- •Patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmia.
- •Patients with bilirubin elevated above institutional upper limit of normal (ULN) must be excluded.
- •Women who are pregnant or breastfeeding are not eligible.
- •Other serious illnesses or medical conditions
结局指标
主要结局
To assess feasibility of one cycle induction chemotherapy of Abraxane plus Carboplatin followed by low-dose sensitizing Abraxane and radiation followed by consolidation Abraxane and carboplatin for stage III NSCLC.
时间窗: 4 years
次要结局
- To estimate the local tumor response rate(4 years)
- To estimate 2-year in-field tumor control.(6 year)
- To estimate 2-year disease free survival (DFS).(6 years)
- To estimate 2-year overall survival (OS).(6 years)
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Study of Abraxane and Carboplatin to Treat Small Cell Lung CancerSmall Cell Lung CancerNCT00454324UNC Lineberger Comprehensive Cancer Center30
已完成
2 期
Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung CancerNon-small Cell Lung CancerSquamous Cell CarcinomaNCT01631357Tianjin Medical University Cancer Institute and Hospital96
已完成
3 期
Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk MedulloblastomaAnaplastic MedulloblastomaMedulloblastomaSupratentorial Embryonal Tumor, Not Otherwise SpecifiedUntreated Childhood Supratentorial Primitive Neuroectodermal TumorNCT00336024Children's Oncology Group91
已完成
3 期
Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung CancerAdenocarcinoma of the LungAdenosquamous Cell Lung CancerBronchoalveolar Cell Lung CancerLarge Cell Lung CancerSquamous Cell Lung CancerStage IB Non-small Cell Lung CancerNCT00002852National Cancer Institute (NCI)500
已完成
3 期
Combination Chemotherapy Followed by Second-Look Surgery and Radiation Therapy in Treating Children With Nonmetastatic Medulloblastoma or Primitive Neuroectodermal TumorUntreated Childhood MedulloblastomaUntreated Childhood Supratentorial Primitive Neuroectodermal TumorNCT00006461Children's Oncology Group82