NCT00433563已完成不适用
A 2-Arm Randomized Controlled Trial of Concurrent Chemo-Radiotherapy Comparing Twice-Daily and Once-Daily Radiotherapy Schedules in Patients With Limited Stage Small Cell Lung Cancer (SCLC) and Good Performance Status [CONVERT]
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 547
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, 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 which schedule of radiation therapy is more effective when given together with chemotherapy in treating small cell lung cancer.
PURPOSE: This randomized phase III trial is studying two different schedules of radiation therapy to compare how well they work when given together with cisplatin and etoposide in treating patients with limited stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare overall survival of patients with limited stage small cell lung cancer treated with chemoradiotherapy comprising cisplatin, etoposide, and once vs twice daily radiotherapy.
Secondary
- Compare local progression-free survival of patients treated with these regimens.
- Compare metastasis-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare response rates in patients treated with these regimens.
- Compare the cytotoxic dose intensity of these regimens in these patients.
- Compare the dose intensity of two different schedules of radiotherapy in these patients.
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
- 未提供
排除标准
- •Either sex, age ≥18 years
- •Performance status ECOG grade 0-
- •Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator. Patients with PS 2 as a result of comorbid conditions will be excluded.
- •Histologically or cytologically confirmed SCLC
- •No patients with mixed small-cell and non-small-cell histologic features
- •No history of previous malignancy in the last 5 years (except non melanomatous skin or in-situ cervix carcinoma). Patients with previous malignancies (except breast cancer) and in remission for at least 5 years can be included.
- •Limited stage disease (Veterans Administration Lung Cancer Study Group) ie patients whose disease can be encompassed within a radical radiation portal.
- •No pleural or pericardial effusions proven to be malignant
- •RT target volume acceptable by the local radiotherapist
- •Pulmonary function
- •FEV1 >1 litre or 40% predicted value
- •KCO (DLCO/VA) >40%predicted
- •Maximum of one of the following adverse biochemical factors:
- •Serum alkaline phosphatase more than >1.5 times the upper limit of normal (ULN)
- •Serum sodium < Lower limit of Normal
- •Serum LDH > ULN
- •Normal serum creatinine and calculated creatinine clearance >50 ml/min. If calculated creatinine clearance is <50 ml/mn according to the Cockroft and Gault formula, an EDTA clearance should be performed
- •Adequate haematological function
- •Neutrophils >1.5 x 109/l
- •Platelets >100 x 109/l
- •Adequate liver function: ALT & AST <= 2.5 x ULN
- •No other previous or concomitant illness or treatment which in the opinion of the clinician will interfere with the trial treatments or comparisons
- •No prior surgical resection of the primary tumour, no prior radiotherapy for lung cancer
- •Considered fit to receive any of the trial regimens
- •Female patients must satisfy the investigator that they are not pregnant, or are not of child-bearing potential, or are using adequate contraception. Men must also use adequate contraception, as etoposide is clastogenic.
- •Patients must not be breastfeeding
- •Patient has read the patient information sheet and has signed the consent form.
- •Patients available for follow-up
研究组 & 干预措施
Once daily radiotherapy
Experimental
Once daily radiotherapy
干预措施: Once daily radiotherapy (Radiation)
Once daily radiotherapy
Experimental
Once daily radiotherapy
干预措施: Twice daily radiotherapy (Radiation)
Twice daily radiotherapy
Active Comparator
Twice daily radiotherapy
干预措施: Once daily radiotherapy (Radiation)
Twice daily radiotherapy
Active Comparator
Twice daily radiotherapy
干预措施: Twice daily radiotherapy (Radiation)
结局指标
主要结局
Overall survival
时间窗: August 2015
次要结局
- Cytotoxic dose intensity(August 2015)
- Radiotherapy dose intensity(August 2015)
- Local progression-free survival(August 2015)
- Metastasis-free survival(August 2015)
- Toxicity of treatment(August 2015)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
G-CSF and Pegfilgrastim in Treating Neutropenia in Patients Undergoing Radiation Therapy and Chemotherapy for Limited Stage Small Cell Lung CancerLung CancerNCT00554463Radiation Therapy Oncology Group5
已完成
3 期
Etoposide and Cisplatin or Carboplatin as First-Line Chemotherapy With or Without Pravastatin in Treating Patients With Small Cell Lung CancerLung CancerNCT00433498University College, London846
已完成
3 期
High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade GliomasCentral Nervous System TumorBrain TumorNCT00078988Children's Oncology Group1
Unknown
2 期
Cisplatin, Capecitabine, and Radiation Therapy With or Without Cetuximab in Treating Patients With Esophageal CancerEsophageal CancerNCT00509561Wales Cancer Trials Unit259
已完成
3 期
Carboplatin and Etoposide With or Without Thalidomide in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung CancerLung CancerNCT00061919University College, London724