A Randomized Phase II Trial of Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
Concurrent chemoradiation (ChRT) is a standard care for unresectable stage III non-small cell lung cancer (NSCLC) patients with good performance status, and cisplatin/etoposide (EP) regimen is one of the most commonly used regimens. However, the prognosis of these patients is still rather poor. It has been demonstrated that Cyclooxygenase (COX)-2 plays an important role in the pathogenesis of lung cancer. Selective (COX)-2 inhibitors can promote chemosensitivity and radiosensitivity of tumor cells in preclinical trials.
This is a single-institution, open-label, randomized phase II trial of celecoxib administered concurrently with cisplatin, etoposide, and radiation therapy in patients with locally advanced NSCLC, to determine the feasibility, activity, and toxicity of this combination on unresectable NSCLC, and further to examine biomarkers to predict response to the treatment.
详细描述
Celecoxib is a non-steroidal-anti-inflammatory drug (NSAIDS) Recent studies have shown that celecoxib has antitumor activity, and may increase the tumor sensitivity to radiation. Furthermore, evidence has shown the safety and efficiency of celecoxib in some phase I/II studies. The purposes of this study are to examine the effects of a new combination of celecoxib (Celebrex®) and cisplatin/etoposide (EP regimen), with concurrent thoracic radiotherapy on unresectable stage III NSCLC patients; and to examine biomarkers to predict response to the treatment. Because of poor survival of patients with unresected locally advanced NSCLC, the efficiency of celecoxib plus concurrent EP chemoradiotherapy need to be further investigated.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 18-70 years old, male or female
- •Histological or cytological evidence of NSCLC.
- •Unresectable Stage III NSCLC.
- •Karnofsky score: at least
- •Estimated survival: at least 6 months
- •Not receiving radiotherapy or combined modality therapy to treat another malignancy.
- •No history of active gastric ulcer, active GI bleeding, or renal failure.
- •No severe hypertension, cardiac disease, or diabetes mellitus
- •Normal blood routine and chemical tests
- •Patients or guardian must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
排除标准
- •• Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
- •Extensive distant metastases
- •Pregnancy or in lactation
- •Allergic to Sulfonamides, NSAIDS or Celebrex
- •Routine use of NSAIDS such as high dose of Aspirin
- •History of cardiovascular diseases including: myocardial infraction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery in the last 6 months.
- •Abnormal coagulation or history of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous, family history of protein S or C deficiencies, prior heparin-induced thrombocytopenia, Factor V Leiden deficiencies or high homocysteine levels.
研究组 & 干预措施
Celecoxib
Combination of and concurrent radiotherapy Cisplatin/etoposide with or without Celecoxib.
Intervention: Drug: Celecoxib
干预措施: Celecoxib (Drug)
结局指标
主要结局
overall survival
时间窗: 3 year overall survival
次要结局
- progression-free survival(3 year progression-free survival)
研究者
Luhua Wang
Luhua Wang
Chinese Academy of Medical Sciences