NCT00021112终止2 期
Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy
European Organisation for Research and Treatment of Cancer - EORTC10 个研究点 分布在 4 个国家目标入组 5 人开始时间: 2001年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 10
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the incidence of radically resected disease in patients with stage IIIB non-small cell lung cancer treated with induction cisplatin, etoposide, and radiotherapy followed by surgical resection.
- Determine the toxicity (morbidity and mortality) of this regimen in these patients.
- Determine the clinical response rate and pathological response rate in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy repeats every 3 weeks for 3 courses. Beginning on day 2 of the second course of chemotherapy, patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks. Chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity.
At 3-6 weeks after completion of the last dose of induction radiotherapy, patients undergo lobectomy or pneumonectomy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed primary stage IIIB non-small cell lung cancer (NSCLC)
- •T4, any N, M0 or any T, N3, M0
- •No N3 disease due to scalene or supraclavicular lymph node involvement
- •No primary tumors located in the lower lobe combined with contralateral upper higher mediastinal lymph node involvement
- •No mixed tumor types with small cell lung cancer
- •At least 1 unidimensionally measurable target lesion
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •No pre-existing pleural or pericardial effusion
- •No CNS involvement by CT scan or MRI
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm ^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST/ALT no greater than 1.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.25 times ULN
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No clinical evidence of superior vena cava syndrome
- •Postoperative FEV1 and KCO greater than 40% predicted
- •VO2 max greater than 15 mL/min/kg (if postoperative KCO no greater than 40% predicted)
- •No other primary malignancy except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or other malignancy treated more than 5 years ago without recurrence (excluding melanoma, breast cancer, or hypernephroma)
- •No active uncontrolled infection requiring IV antibiotics
- •No pre-existing sensory neurotoxicity grade 2 or greater
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior immunotherapy for NSCLC
- •No concurrent immunotherapy during induction chemoradiotherapy
- •Concurrent colony stimulating factors allowed
- •Chemotherapy:
- •No prior chemotherapy for NSCLC
- •Endocrine therapy:
- •No concurrent anticancer hormonal agents (except corticosteroids for antiemetic prophylaxis) during induction chemoradiotherapy
- •Radiotherapy:
- •No prior radiotherapy for NSCLC
- •No prior surgery for NSCLC
- •No other concurrent anticancer drugs during induction chemoradiotherapy
排除标准
- 未提供
研究者
研究点 (10)
Loading locations...
相似试验
Unknown
2 期
Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung CancerLung CancerNCT00006116GERCOR - Multidisciplinary Oncology Cooperative Group
Unknown
2 期
Docetaxel Plus Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung CancerLung CancerNCT00003562Hope Cancer Institute, Inc.38
已完成
2 期
Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With NeuroblastomaNeuroblastomaNCT00017225German Society for Pediatric Oncology and Hematology GPOH gGmbH
终止
2 期
S0122: Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Limited-Stage Small Cell Lung CancerLung CancerNCT00045617SWOG Cancer Research Network9
Unknown
3 期
Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically RemovedLung CancerNCT00003053European Institute of Oncology750