Non-small cell lung cancer Cancer Malignant neoplasm of bronchus and lung
Conditions
Interventions
Dose escalation will be through an individual patient-based model, associated with an acceptable level of grade 3 toxicity (from oesophagus or lung).
Radiotherapy (30 single daily fra
Sponsors
University College London (UCL) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 03/11/2011: Oesophagitis: Grade 2-5 according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0 - appendix 1) acute oesophagitis during RT or within 3 months from the first dose of RT for all patients. Pneumonitis: Early Radiation Pneumonitis (ERTP) determined by grade 2 - 5 according to CTCAE v4.0 toxicity rates occurring within 6 months from the first dose of RT for all patients. Previous primary outcome measures: Oesophagitis: Grade 2 - 5 according to Common Terminology Criteria For Adverse Events v4.0 (CTCAE v4.0) acute oesophagitis during RT or within 6 months from the first dose of RT rate for all patients. In IDEAL-CRT this will be used for 6 months post-RT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 03/11/2011: Oesophagus: Chronic oesophageal stricture rate: grade 1 - 5 according to Radiation Therapy Oncology Group (RTOG) late toxicity scales from 3 months post-RT for all patients. Lung: 1. Pneumonitis grades 2 - 5 (CTCAE v4.0) 6 or more months after end of RT for all patients 2. Changes from baseline in FEV1, forced vital capacity (FVC) and DLCO (CTCAE v4.0 grades 2 - 5) 3. Any grade 2 - 5 pulmonary toxicity according to CTCAE v4.0 from start of RT to death Previous secondary outcome measures: 3. Any grade 2 - 5 pulmonary toxicity according to CTCAE v4.0 from start of RT to 12 months post-RT | — |
Countries
England, United Kingdom
Outcome results
None listed