A RANDOMIZED PHASE I/II STUDY OF NAB-PACLITAXEL, OR PACLITAXEL, PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY FOLLoWED BY CONSOLIDATION IN PATIENTS WITH FAVORABLE PROGNOSIS INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 5
- 主要终点
- 2-year Overall Survival (Phase II)
研究概览
简要总结
The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane) at 50mg/m2, and then will begin enrolling patients into the phase II component using either Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation or paclitaxel with carboplatin concurrent with daily radiation.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented NSCLC; Patients must be M
- •Patients with T1-T2 with N2 or T3N1-2 are eligible, if inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable.
- •Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. The boost volume must be limited to < 50% of the ipsilateral lung volume.
- •Patients with Zubrod performance status 0-1
- •Adequate hematologic function
- •FEV1 with ≥ 1200 cc or ≥ 50% predicted
排除标准
- •Prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for any reason and/or surgical resection of present cancer
- •Exudative, bloody, or cytologically malignant effusions
- •Prior therapy with any molecular targeted drugs (for lung cancer)
- •Active pulmonary infection not responsive to conventional antibiotics
- •Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease >2 (see Appendix B) within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
- •Patients with > grade 1 neuropathy
研究组 & 干预措施
PACLITAXEL (Phase II, Arm A)
PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY
干预措施: PACLITAXEL (Drug)
NAB-PACLITAXEL (Phase II, Arm B)
NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks
干预措施: NAB-PACLITAXEL (Drug)
NAB-PACLITAXEL (Phase I)
NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks
干预措施: NAB-PACLITAXEL (Drug)
结局指标
主要结局
2-year Overall Survival (Phase II)
时间窗: 2 years
2-year overall survival, as measured (by Kaplan-Meir method) as the percentage of patients who were randomized and received carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy survived for 2 years.
次要结局
- EuroQol-5Dimension (EQ-5D) VAS Score at Baseline(Baseline)
- The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy(60 days of the start of treatment)
- Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy(1,6,12,18,24 month)
- EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment(End of Treatment (6 weeks))
- EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month(24 month follow up)
- Proportion of Participants With Progression-free Survival (Phase II)(2 years)
- Median Overall Survival (Phase II)(every 6 months up to 24 months (approx. 22 months))
- EuroQol-5Dimension (EQ-5D) MUS Score at Baseline(Baseline)
- EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment(End of treatment (6 weeks))
- EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up(24 month follow up)
研究者
Yuanyuan Zhang
Instructor of Department of Radiation Oncology
University of Texas Southwestern Medical Center