Combination Chemotherapy Followed by Surgery in Treating Patients With Non-small Cell Lung Cancer
Preoperative Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with docetaxel and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer.
研究概览
详细说明
OBJECTIVES: I. Assess the efficacy and toxic effects of docetaxel plus cisplatin in patients with stage IIIA non-small cell lung cancer. II. Assess the clinical and pathological response rate to this therapy in this patient population. III. Compare the benefit of surgery in terms of overall survival of responding and nonresponding patients.
OUTLINE: Patients receive infusions of docetaxel over 1 hour on day 1, followed by infusions of cisplatin over 1 hour on days 1-2. Treatment is repeated for three 21 day courses. Patients undergo tumor resection and mediastinal lymph node dissection. Patients are to receive postoperative radiotherapy within 4 weeks of resection if the tumor reaches the resection margins and/or the first mediastinal lymph node levels are involved. Patients will be followed until death.
PROJECTED ACCRUAL: Approximately 5-40 patients will be accrued within 3 years.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Aarau、瑞士、5001
- Kantonspital Aarau
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Basel、瑞士、CH-4031
- University Hospital
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Basel、瑞士、CH 4051
- Office of Walter Weber-Stadelman
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Bern、瑞士、CH-3010
- Inselspital, Bern
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Geneva、瑞士、CH-1211
- Hopital Cantonal Universitaire de Geneva
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Lugano、瑞士、CH-6900
- Istituto Oncologico della Svizzera Italiana
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Solothurn、瑞士、4500
- Burgerspital, Solothurn
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Zurich、瑞士、8063
- City Hospital Triemli
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Zurich、瑞士、CH-8008
- Klinik Hirslanden
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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
DISEASE CHARACTERISTICS: Histologically proven stage IIIA non-small cell lung cancer (NSCLC)(including squamous, adenocarcinoma, large cell, and poorly differentiated NSCLC) Nodal metastases of T1-3 N2 M0 No distant metastases
PATIENT CHARACTERISTICS: Age: 18 to 75 Performance Status: WHO 0-2 Life Expectancy: Not specified Hematopoietic: Leucocytes greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin within normal limits AST or ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine clearance greater than 60 mL/min No hypercalcemia Cardiovascular: No unstable cardiac disease No congestive heart failure No angina pectoris No significant arrhythmias No prior history of myocardial infarction within 3 months Pulmonary: Lung function test with a forced expiratory volume greater than 1.2 L/sec Neurologic: No dementia No peripheral neuropathy greater than grade 1 No psychosis No seizure disorders Other: No prior or concurrent malignancies, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix No active uncontrolled infection or other serious medical conditions No diabetes mellitus treated with insulin No gastric ulcers
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No prior corticosteroids or other endocrine therapy No concurrent treatment with prednisone (except for prophylaxis, treatment of acute hypersensitivity, or chronic treatment initiated greater than 6 months prior to study entry) Radiotherapy: No prior radiotherapy Surgery: No prior surgery for malignancy Other: No concurrent treatment with other experimental drugs No involvement in clinical trials within 30 days of study No prior treatment with other cytostatic therapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
合作者和调查者
调查人员
- 学习椅：Daniel C. Betticher, MD、University Hospital Inselspital, Berne
出版物和有用的链接
一般刊物
- Betticher DC, Hsu Schmitz SF, Totsch M, Hansen E, Joss C, von Briel C, Schmid RA, Pless M, Habicht J, Roth AD, Spiliopoulos A, Stahel R, Weder W, Stupp R, Egli F, Furrer M, Honegger H, Wernli M, Cerny T, Ris HB; Swiss Group for Clinical Cancer Research (SAKK). Prognostic factors affecting long-term outcomes in patients with resected stage IIIA pN2 non-small-cell lung cancer: 5-year follow-up of a phase II study. Br J Cancer. 2006 Apr 24;94(8):1099-106. doi: 10.1038/sj.bjc.6603075.
- Betticher D, Hsu Schmitz S, Roth A, et al.: Neoadjuvant therapy with docetaxel and cisplatin in patients with non-small cell lung cancer (NSCLC), stage IIIA, pN2: a large phase II study with 59 months of follow-up. [Abstract] Lung Cancer 50 (Suppl 2): A-O-032, S14, 2005.
- Betticher DC, Hsu Schmitz SF, Totsch M, Hansen E, Joss C, von Briel C, Schmid RA, Pless M, Habicht J, Roth AD, Spiliopoulos A, Stahel R, Weder W, Stupp R, Egli F, Furrer M, Honegger H, Wernli M, Cerny T, Ris HB. Mediastinal lymph node clearance after docetaxel-cisplatin neoadjuvant chemotherapy is prognostic of survival in patients with stage IIIA pN2 non-small-cell lung cancer: a multicenter phase II trial. J Clin Oncol. 2003 May 1;21(9):1752-9. doi: 10.1200/JCO.2003.11.040.
- Fruh M, Betticher DC, Stupp R, Xyrafas A, Peters S, Ris HB, Mirimanoff RO, Ochsenbein AF, Schmid R, Matzinger O, Stahel RA, Weder W, Guckenberger M, Rothschild SI, Lardinois D, Mach N, Mark M, Gautschi O, Thierstein S, Biaggi Rudolf C, Pless M; Swiss Group for Clinical Cancer Research (SAKK). Multimodal Treatment in Operable Stage III NSCLC: A Pooled Analysis on Long-Term Results of Three SAKK trials (SAKK 16/96, 16/00, and 16/01). J Thorac Oncol. 2019 Jan;14(1):115-123. doi: 10.1016/j.jtho.2018.09.011. Epub 2018 Sep 26.
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 (实际的)
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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