ACTRN12612001211853进行中（未招募）3 期
TROG 11.03 A Randomised Phase III Trial of High Dose Palliative Radiotherapy (HDPRT) Versus Concurrent Chemotherapy + HDPRT (C-HDPRT) in Patients with Good Performance Status, Locally Advanced/Small Volume Metastatic Non Small Cell Lung Cancer (NSCLC) Not Suitable for Radical Chemo-Radiotherapy (P_LUNG GP)
Trans Tasman Radiation Oncology Group0 个研究点目标入组 130 人开始时间: 2012年11月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 100 Years（—）
- 性别
- All
入选标准
- •1. Aged 18 years or older
- •2. ECOG PS 0-1,
- •3. Histological or cytological proven stage III or IV NSCLC of any subtype: Adenocarcinoma, Squamous Cell Carcinoma (SCC), NSCLC Not Otherwise Specified (NOS) or Other (including Large Cell Undifferentiated).
- •4. Symptoms due to intrathoracic disease (at least one of cough, dyspnoea, haemoptysis, chest pain),
- •5. Patients with Stage III NSCLC not suitable for radical chemo-radiotherapy (due to concurrent medical illness, weight loss > 10% or tumour volume too large for radical radiation fields (e.g. dose constraints for organs at risk cannot be met using radical radiation fields or at the discretion of the investigator) or patients with locally advanced thoracic disease and a FDG-PET detected solitary metastasis (small volume Stage IV disease), Not cerebral metastasis
- •6. Planned for HDPRT to achieve local control
- •7. Adequate organ function;
- •a) Bone marrow: Haemoglobin (Hb) >/= 100g/l, Absolute neutrophil count (ANC) >/= 1.5 , Platelet count >/= 100
- •b) Hepatic: Serum bilirubin
- •c) Renal: Creatinine Clearance >/= 55 ml/min
- •8. No prior therapy for NSCLC
- •9. Able to commence Radiotherapy no later than 6 weeks, but preferably within 4 weeks from the time of participant randomisation. It is preferred that RT be commenced on a Monday or Tuesday.
- •10. Has provided written informed consent to participate in this trial
- •11. Participants capable of childbearing are using adequate contraception
- •12. Available for follow-up for a minimum of 3 months.
排除标准
- •1. Receiving treatment with another investigational agent
- •2. History of any other cancer (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 3 years.
- •3. Women who are pregnant or lactating
- •4. Previous radiotherapy to the area to be treated, at any time.
- •5. Significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities
研究者
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