NCT00238615终止2 期
A Phase II Trial of Concurrent Docetaxel (Taxotere) / Carboplatin / Radiotherapy Followed by Surgical Resection Followed by Consolidation Taxotere / Carboplatin in Stage III Non-Small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- 2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.
研究概览
简要总结
The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 stage IIIA or IIIB NSCLC
- •Patients must have measurable disease
- •No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC.
- •Age>18 years
- •Life expectancy >12 months
- •ECOG performance status 0-1
- •Normal organ and marrow function
- •Medically fit for surgery at time of enrollment.
- •Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment.
- •Ability to understand and willingness to sign the consent form.
排除标准
- •Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC.
- •Patients receiving any other investigational agents.
- •Known metastatic disease (brain or any other site)
- •History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study.
- •Peripheral neuropathy >grade 1
- •Uncontrolled concurrent illness
- •Pregnant women
- •Weight loss>10% in the past 3 months before diagnosis.
- •Hyperglycemia - exclusion from PET analysis
- •HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.
研究组 & 干预措施
Chemotherapy+Radiation+Surgery
Experimental
- Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy.
- Complete surgical excision 3-6 weeks after completion of chemoradiotherapy.
- No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation
- Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
干预措施: Docetaxel (Drug)
Chemotherapy+Radiation+Surgery
Experimental
- Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy.
- Complete surgical excision 3-6 weeks after completion of chemoradiotherapy.
- No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation
- Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
干预措施: Carboplatin (Drug)
Chemotherapy+Radiation+Surgery
Experimental
- Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy.
- Complete surgical excision 3-6 weeks after completion of chemoradiotherapy.
- No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation
- Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
干预措施: Radiation therapy (Procedure)
Chemotherapy+Radiation+Surgery
Experimental
- Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy.
- Complete surgical excision 3-6 weeks after completion of chemoradiotherapy.
- No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation
- Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
干预措施: Surgical resection (Procedure)
结局指标
主要结局
2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.
时间窗: Two years
Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.
次要结局
- Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival(baseline, 5 weeks after combined chemo-radiation)
研究者
Heather Wakelee
Assistant Professor of Medicine
Stanford University
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate CancerProstate CancerNCT00099086Medical University of South Carolina20
终止
2 期
Salvage Radiation Therapy and Taxotere for PSA Failure After Radical ProstatectomyProstate CancerNCT00480857University of Michigan Rogel Cancer Center19
终止
2 期
Phase II Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer PatientsProstate CancerNCT00714376CHU de Quebec-Universite Laval6
Unknown
2 期
Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before SurgeryBreast CancerNCT00251329Cancer Research Network48
Unknown
2 期
Docetaxel With or Without Low-dose, Short Course Sunitinib in Refractory Solid TumorsSolid TumorsNon-small Cell Lung CancerGastric CancerBreast CancerProstate CancerNCT01803503National University Hospital, Singapore80