A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Biopsy-Proven N2 Stage IIIA Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- To estimate the time to recurrence
研究概览
简要总结
It is suggested that a bimodal or trimodal approach combining neoadjuvant chemotherapy with or without radiotherapy followed by surgery provides a potentially superior method of enhancing resectability and improving locoregional control and survival compared to radiotherapy alone followed by surgery. Unsolved questions are the identification of the best induction strategy, the impact of surgery on long-term survival, and the contribution of radiation therapy in this setting. Thus, the investigators conduct a phase II trial to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with biopsy proven N2 stage IIIA NSCLC to address optimal induction strategy.
详细描述
Preoperative Therapy Arm 1. (preoperative chemotherapy) Paclitaxel (90 mg/m2)on day 1 and 8 Cisplatin (40 mg/m2)on day 1 and 8. q 3 weeks, 2 cycles
Arm 2. (preoperative chemoradiotherapy) Paclitaxel (50 mg/m2)on day 1, 8, 15, 22 & 29 Cisplatin (20 mg/m2)on day 1, 8, 15, 22 & 29. Thoracic radiation therapy (TRT) 1.8 Gy daily, five times per week (45 Gy target dose in 5 weeks).
Postoperative Consolidation Chemotherapy:
Paclitaxel (90 mg/m2) on day 1 and 8. Cisplatin (40 mg/m2) on day 1 and 8. q 3weeks, 2 cycles
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
- 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
- •Histologic or cytologic diagnosis of non-small cell lung cancer.
- •Presence of biopsy-proven N2 stage IIIA, according to the American Joint Committee on Cancer (AJCC), with none of the mediastinal lymph nodes > 3 cm in largest diameter.
- •Tumor amenable to surgical resection.
- •At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
- •No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy).
- •Performance status of 0-1 on ECOG scale.
- •At least 18 years old.
- •Patient compliance that allows adequate follow-up.
- •Medical fitness of patients adequate for radical NSCLC surgery.
- •Adequate organ function including the following:Adequate hematologic function: WBC count ≥ 4,000/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, platelet count ≥ 100,000/uL, and hemoglobin ≥ 10 gm/dL.Adequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.
- •Signed informed consent from patient or legal representative.
- •Patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. Females with childbearing potential must have a negative urine hCG test within 7 days prior to study enrollment.
排除标准
- •Concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy.
- •Active uncontrolled infection.
- •Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
- •MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.
- •Significant neurological or mental disorder.
- •Second primary malignancy.
- •Pregnant or nursing.
研究组 & 干预措施
study arm
pre-operative chemotherapy (Pac/Cis)
干预措施: chemotherapy (Drug)
study arm 2
Pre-operative concurrent chemoradiation therapy
干预措施: Concurrent chemoradiation therapy (Radiation)
结局指标
主要结局
To estimate the time to recurrence
时间窗: The interval from the date of randomization to the date to the date of the first objective evidence of recurrence or to the date of death, if before recurrence
次要结局
- To estimate the overall survival(from the date of randomization to the date of death)
- To assess the pathologic complete response rate and the complete resection rate(After surgery)
- To estimate toxicities(from the first date of treatment to 30 days after the last dose of study drug)