ISRCTN12155469已完成1 期
A phase I/II multicentre interventional trial of concurrent chemoradiation with dose-escalated radiotherapy in patients with stage II or stage III non-small cell lung cancer
niversity College London (UCL) (UK)0 个研究点目标入组 105 人开始时间: 2009年11月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
研究概览
简要总结
2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27296040 results 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31809876 long-term results (added 21/04/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically or cytologically confirmed NSCLC
- •2. Stages: IIa, IIb, IIIa and IIIb (according to International Union Against Cancer Classification of Malignant Tumors [UICC TNM] 7th Edition 2009) (Stage IIa added as of 03/11/2011)
- •3. World Health Organization (WHO) performance status 0 or 1
- •4. Life expectancy greater than 6 months
- •5. Inoperable disease as assessed by a lung cancer multi-disciplinary team (MDT); or operable but MDT agrees that chemoradiotherapy (chemoRT) is a suitable alternative to surgery; or operable but the patient refuses surgery
- •6. Radiotherapy dose constraints consistent with minimum prescription dose of 63 Gy in 30 fractions
- •7. Age 18 or over (no upper age limit), either sex
- •8. No prior thoracic radiotherapy
- •9. No prior lobectomy/pneumonectomy
- •10. No prior systemic chemotherapy
- •11. Willing and able to give informed consent
- •12. Adequate pulmonary function test (PFT) results:
- •12.1. Forced expriatory volume in one second (FEV1) greater than or equal to 40% of predicted, or greater than or equal to 1 litre
- •12.2. Diffusing capacity of the lung for carbon monoxide (DCLO) greater than or equal to 40% of predicted
- •13. For women with childbearing potential:
- •13.1. Negative pregnancy test
- •13.2. Adequate contraceptive precautions during the trial and for 3 months after trial treatment
- •14. Haematology and biochemistry baselines suitable for cisplatin/vinorelbine chemotherapy
- •15. Renal function adequate for chemotherapy greater than or equal to 60 ml/min. If glomerular filtration rate (GFR) less than 60 ml/min (Cockroft & Gault-Appendix 7), check GFR with EDTA clearance or equivalent
- •Added 03/11/2011:
- •16. In the clinician's view the patient is fit to tolerate the trial treatment without exceptional risk of complications or likelihood of re-planning
排除标准
- •1. Radiotherapy dose constraints not consistent with minimum prescription dose of 63 Gy in 30 fractions
- •2. Clinically diagnosed NSCLC without cytological or histological evidence of non-small cell lung cancer
- •3. Previous or current malignant disease likely to interfere with the protocol treatment or comparisons
- •4. Upper lobe tumours if the brachial plexus is within the high-dose volume
- •5. Medically unstable (e.g. unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcaemia, ischaemic heart disease)
- •6. Women of childbearing potential who are not practicing adequate contraceptive precautions
- •7. Women who are pregnant or lactating
- •8. Chronic liver disease and/or bilirubin greater than 35
- •9. Chronic renal disease and/or calculated creatinine clearance less than 60 ml/min
- •10. Connective tissue disorders (e.g. scleroderma, systemic lupus erythematosus)
- •11. Inability to comply with protocol or trial procedures
- •12. History of prior malignant tumour, unless the patient has been without evidence of disease for at least 3 years or the tumour was a non-melanoma skin tumour or early cervical cancer
- •Added as of 03/11/2011:
- •13. Patients presenting with a collapsed lung or collapse of an entire lobe
- •14. In the clinician's view there is an exceptional risk of complications or likelihood of re-planning associated with the trial treatment for this patient
研究者
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