IDEAL-CRT: A Phase I/II trial of concurrent chemoradiation with dose-escalated radiotherapy in patients with stage II or stage III non-small cell lung cancer
- Conditions
- on-small cell lung cancerCancerMalignant neoplasm of bronchus and lung
- Registration Number
- ISRCTN12155469
- Lead Sponsor
- niversity College London (UCL) (UK)
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 105
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method