Induction Chemotherapy With Carboplatin and Navelbine Oral(R) Followed by Concomitant Navelbine Oral(R) and Irradiation in Local-regionally Advanced Non-small Cell Lung Cancer. A Randomized Phase II Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 6
- 主要终点
- Local Failure Free Survival
研究概览
简要总结
This study is an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curatively intended irradiation. The treatment plan consists of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. The patients will be included in the study after completing the induction chemotherapy. Randomization will take place only if an acceptable dose plan can be obtained.
详细描述
This study was an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curatively intended irradiation. The treatment plan consisted of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. The patients was included in the study after completing the induction chemotherapy. Randomization took place only if an acceptable dose plan could be obtained.
Primary endpoint: local recurrence free interval
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
盲法说明
No blinding after randomization
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Patients with histologically or cytologically documented diagnosis of locally advanced NSCLC stage IIB to IIIB without pleural effusion
- •Performance status 0-1 on the ECOG scale
- •Weight loss ≤10% during the last 6 months
- •Adequate lung function measured as FEV1 ≥1.0
- •Neutrophile count ≥1.5 x 109/L and platelet count ≥100 x 109/L
- •Serum bilirubin ≤1.5 upper limit of normal (ULN)
- •ALAT ≤2 x ULN
- •Able to comply with study and follow-up procedures
- •Patients with reproductive potential must use effective contraception
- •Written (signed) informed consent to participate in the study
排除标准
- •Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
- •Any other active malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
- •Prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy
- •Inability to take oral medication, or requirement of intravenous alimentation
- •Active peptic ulcer disease
- •Nursing mothers
研究组 & 干预措施
B: 66Gy/33F+Navelbine oral 150 mg q3w
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).
Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
干预措施: Navelbine (Drug)
B: 66Gy/33F+Navelbine oral 150 mg q3w
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).
Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
干预措施: 66 Gy/33F (Radiation)
A: 60Gy/30F+Navelbine oral 150 mg q3w
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
干预措施: Navelbine (Drug)
A: 60Gy/30F+Navelbine oral 150 mg q3w
Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
干预措施: 60 Gy/30F (Radiation)
结局指标
主要结局
Local Failure Free Survival
时间窗: 9 months
Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT
次要结局
- Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy(9 months)
- Local Tumour Control(9 months)
- Overall Survival(72 months)
- Late Toxicity(48 months)
- Disease Free Survival(72 months)
研究者
Olfred Hansen
MD, Professor
Odense University Hospital