A Randomized Phase III Trial of Sequential Chemotherapy Followed By Radical Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Chemotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer and Good Performance Status
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Treatment related mortality (any cause)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving combination chemotherapy followed by radiation therapy is more effective than giving combination chemotherapy together with radiation therapy followed by more chemotherapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to combination chemotherapy combined with radiation therapy followed by more chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Compare the overall survival of patients with stage III non-small cell cancer treated with chemotherapy comprising cisplatin and vinorelbine ditartrate (CV) followed by radical radiotherapy versus concurrent CV chemoradiotherapy followed by CV chemotherapy.
Secondary
- Compare the progression-free survival of patients treated with these regimens.
- Compare the local progression-free survival (local control).
- Compare the hematological, pulmonary, esophageal, and neurological toxicities.
- Compare the response.
- Compare the quality of life.
- Compare the cost-effectiveness.
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC)
- •Patients with stage IIIB disease must not have a pleural effusion that is cytologically proven to be malignant
- •Inoperable disease
- •Disease must be able to be encompassed within a radical radiotherapy treatment volume
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0 or 1
- •Life expectancy > 3 months
- •Patient considered able to tolerate platinum-based chemotherapy and radical radiotherapy
- •Glomerular filtration rate ≥ 60 mL/min
- •WBC > 3,000/mm³
- •Absolute neutrophil count > 1,500/mm³
- •Hemoglobin > 10.0 g/dL
- •Patients with hemoglobin between 10 and 12 g/dL at randomization require a blood transfusion to ensure hemoglobin > 12 g/dL before starting radiotherapy
- •Platelet count > 100,000/mm³
- •FEV_1 ≥ 1.0 L or DLCO (transfer factor) ≥ 50% of predicted
- •Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)
- •Gamma-glutamyl-transferase < 1.5 times ULN
- •Transaminases ≤ 1.5 times ULN
- •Bilirubin ≤ 1.5 times ULN
- •No medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcemia, or ischemic heart disease)
- •Not pregnant or nursing
- •Fertile patients must agree to use effective contraception
- •Negative pregnancy test
- •No other previous or current malignant disease likely to interfere with protocol treatment or comparisons
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy, radiotherapy, or investigational agents
排除标准
- 未提供
研究组 & 干预措施
Sequential arm (SEQ)
Four cycles of cisplatinum/vinorelbine given in a 21 day cycle followed by radical radiotherapy, 55 Gy in 20 once daily fractions in four weeks (2.75 Gy/day).
干预措施: Control arm (SEQ): (Drug)
Experimental arm (CON)
Concurrent chemo-radiotherapy [55 Gy in 20 daily fractions in 4 weeks (2.75 Gy/day) with cisplatinum given concurrently with fractions 1-4 and 16-19, and vinorelbine prior to fractions 1, 6, 15 and 20] followed by two cycles of cisplatinum/vinorelbine.
干预措施: Experimental arm (CON): (Drug)
结局指标
主要结局
Treatment related mortality (any cause)
时间窗: from randomization till death
次要结局
- Local progression-free survival (local control)(From the date of randomisation to the date of first clinical evidence of progressive disease at the primary site, or death)
- Hematological, pulmonary, esophageal, and neurological toxicities(From randomisation to the first 6 months)
- Quality of life(at baseline, every 3 weeks for the first 6 months, then 3 monthly until 2 years, 6 monthly until 3 years, and annually thereafter)
- Cost effectiveness(at baseline, every 3 weeks for the first 6 months, then 3 monthly until 2 years, 6 monthly until 3 years, and annually thereafter)
- Overall survival and progression-free survival.(Overall Survival is the time between date of randomisation and date of death of any cause. Progression-free survival will be calculated from the date of randomisation to the date of first clinical evidence of progressive disease, or death.)
- Response(proportion of patients in each treatment group whose best response in the first 6 months from randomisation is complete or partial will be reported.)