ISRCTN53398136进行中（未招募）未知
Targeted therapy with or without dose intensified radiotHerapy for oligo-progressive disease in oncogene-Addicted Lung Tumours
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 25/10/2021:
- •1. Male or female, =16 years of age
- •2. Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with defined actionable mutation receiving targeted TKI therapy
- •3. Clinical and/or radiologically confirmed response to TKI therapy (assessed locally usually 2-3 months post commencing TKI)
- •4. Confirmed OPD defined as =5 extracranial sites of progressive disease. All sites must be visible, imaging defined targets and suitable for treatment with SBRT as determined by the virtual MDT and in accordance with the HALT Radiotherapy planning and delivery guidance document.
- •5. Adequate baseline organ function to allow SBRT to all relevant targets
- •6. Predicted life expectancy =6 months
- •7. Karnofsky Index =60% and ECOG 0-2
- •8. Provision of written informed consent
- •Previous inclusion criteria:
- •1. Male or female, =16 years of age
- •2. Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with defined actionable mutation receiving targeted TKI therapy
- •3. Clinical and/or radiologically confirmed response to TKI therapy (assessed locally usually 2-3 months post commencing TKI)
- •4. Confirmed OPD defined as =3 extracranial sites of progressive disease. All sites must be visible, imaging defined targets and suitable for treatment with SBRT as determined by the virtual MDT and in accordance with the HALT Radiotherapy planning and delivery guidance document.
- •5. Adequate baseline organ function to allow SBRT to all relevant targets
- •6. Predicted life expectancy =6 months
- •7. Karnofsky Index =60% and ECOG 0-2
- •8. Provision of written informed consent
排除标准
- •Current exclusion criteria as of 25/10/2021:
- •1. >5 extracranial sites of progressive disease
- •2. Progressing or newly diagnosed brain metastases identified at the time of trial entry, not amenable to radical surgery or SRS. Previously treated brain metastases (i.e palliative radiotherapy or systemic therapy) which have remained clinically and radiologically stable for =6 months are permissible.
- •3. Prior radiotherapy near the oligoprogressive lesion precluding ablative SBRT
- •4. Co-morbidities considered clinically to preclude safe use of SBRT e.g. IPF in patients with an oligoprogressive lung lesion, inflammatory bowel disease in patients with an oligoprogressive pelvic lymph node
- •5. Any psychological, sociological or geographical issue potentially hampering compliance with the study
- •6. Pregnancy
- •Previous exclusion criteria:
- •1. >3 extracranial sites of progressive disease
- •2. Brain metastases not amenable to radical surgery or SRS
- •3. Prior radiotherapy near the oligoprogressive lesion precluding ablative SBRT
- •4. Co-morbidities considered clinically to preclude safe use of SBRT e.g. IPF in patients with an oligoprogressive lung lesion, inflammatory bowel disease in patients with an oligoprogressive pelvic lymph node
- •5. Any psychological, sociological or geographical issue potentially hampering compliance with the study
- •6. Pregnancy
研究者
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