Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 13
- 主要终点
- Survival
研究概览
简要总结
Primary objectives of the study are:
To assess the differences in survival of the two treatment options in both stage III (A and B) nonsmall cell lung cancer (NSCLC) (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), respectively
Secondary objectives are:
To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), and To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B
详细描述
To compare survival rates (median and 1-year), and toxicity of two treatment regimens in patients with locally advanced incurable NSCLC (study A), to compare survival rates (median and 1-year) of two treatment regimens in patients with locally advanced and metastatic NSCLC (study B)
To compare HRQoL and cost effectiveness of two treatment regimens in patients with locally advanced incurable NSCLC (study A), and in patients with locally advanced and metastatic NSCLC (study B) and to evaluate the effect of HRQoL assessment on QoL dimensions
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
- Single (Participant)
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 or cytologically confirmed NSCLC
- •Stage IIIA/IIIB staged with
- •CT chest and upper abdomen
- •Liver, renal, hematological reserve appropriate (according to "standard" institutional values)
- •Brain CT and/or bone scan only if clinical symptoms request such investigation
- •Performance status KPS 60-90
- •No second cancer except skin non-melanoma
- •No previous treatment
- •Patient must be contactable for follow-up
- •Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)
- •Life expectancy > 3 months
- •Patient must be able and willing to give informed consent, and fill in questionnaires
排除标准
- •Stage III B "wet" (existing pleural effusion , but not necessarily cytologically verified)
- •RT field > 200 cm2
- •Pregnancy
- •Study B Inclusion Criteria:
- •KPS 60-90
- •Stage IV and Stage III B (existing pleural effusions , but not necessarily cytologically verified)
- •Histologically or cytologically confirmed
- •CT staged disease (thorax and possible upper abdomen)
- •No second cancer except skin non-melanoma
- •Liver, renal, haematological reserve appropriate (according to "standard" institutional values)
- •No previous treatment
- •Patient must be contactable for follow-up
- •Patient must be able and willing to give informed consent and fill in questionnaires
- •Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)
- •Life expectancy > 3 months
- •Study B Exclusion Criteria:
- •Brain metastasis (brain CT and/or MRI not needed, unless symptoms exist - clinically indicated)
- •RT field > 200 cm2
- •Pregnancy
- •A-P separation too large to be adequately treated with 60-Co (?)
研究组 & 干预措施
Radiotherapy
For patients in Group A (Stage IIIA or IIIB), EBRT 39 Gy in 13 daily fractions over, with no chemotherapy.
干预措施: radiation (Radiation)
Chemotherapy and radiotherapy
For patients in Group A (either stage IIIA or IIIB) receive a course of up to 3 cycles of chemotherapy followed by EBRT of 10 Gy in a single fraction or 16 Gy in 2 fractions 1 week apart.
干预措施: Chemotherapy and radiotherapy (Other)
Chemotherapy
For patients in Group B (either stage IIIB (wet) or IV) receive up to 3 cycles of chemotherapy, and no radiotherapy.
干预措施: Chemotherapy (Drug)
Palliative radiotherapy and chemotherapy
For patients in Group B (either stage IIIB (wet) or IV) receive EBRT of 10 Gy in a single fraction or 16 Gy in two fractions 1 week apart, followed by up to 3 cycles of chemotherapy.
干预措施: Palliative radiotherapy and chemotherapy (Other)
结局指标
主要结局
Survival
时间窗: 1 year
次要结局
- To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B)(1 year)
- To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B(1 year)