A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup of resected stage I patients who, following complete surgical resection of their disease, are defined as "high risk" based on the presence of a T2N0 tumor (according to the criteria of the International Staging System for lung cancer).
SECONDARY OBJECTIVES:
I To compare failure-free survival of patients with T2N0 stage I NSCLC who have and have not been treated with adjuvant chemotherapy.
II. To determine the toxicities associated with adjuvant chemotherapy. III. To describe the pattern of disease recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 documented non-small cell carcinoma
- •Completely resected T2N0M0 Stage I NSCLC as defined by the International Staging System
- •Surgery shall consist of a lobectomy or pneumonectomy with resection of associated N1 lymph nodes (either by thoracotomy or thoracoscopy)
- •Patients must be randomized within 4 to 8 weeks from the date of complete surgical resection
- •No prior chemotherapy or radiation for non-small cell lung cancer
- •Performance status of 0 or 1
- •Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study
- •Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has bee disease free for five years
- •Granulocytes >= 1,800/ul
- •Platelets >= 100,000/ul
- •Bilirubin < 1.5 mg/dl
- •SGOT (AST) < 2.0 x ULN
排除标准
- 未提供
研究组 & 干预措施
Arm I (surgery, observation)
Patients receive no further therapy.
干预措施: therapeutic conventional surgery (Procedure)
Arm II (surgery, chemotherapy)
Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.
干预措施: paclitaxel (Drug)
Arm II (surgery, chemotherapy)
Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.
干预措施: carboplatin (Drug)
Arm II (surgery, chemotherapy)
Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 2.4 years
OS curves will be calculated using the Kaplan-Meier life-table method. Comparison of the survival curve for the two treatment regimens will be performed using the log-rank test for censored data.
Failure-free survival
时间窗: Time between randomization and disease relapse or death, assessed up to 2.4 years
Failure-free survival curves will be calculated using the Kaplan-Meier life-table method.
次要结局
- Toxicity as assessed by Common Toxicity Criteria version 2.0(Up to 1 year after completion of treatment)
- Pattern of disease recurrence.(Up to 2 years)