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02 September 2010
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| [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN12155469 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | 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 |
| Acronym | IDEAL-CRT |
| Serial number at source | UCL/08/0201 |
| Study hypothesis | The aim of IDEAL-CRT is to investigate the toxicity, feasibility and potential clinical effectiveness of dose-escalated radiotherapy (RT) with concurrent chemotherapy in stage IIb or stage III non-small cell lung cancer (NSCLC) as a potential experimental arm in future phase III trials. It will also allow the assessment and validation of radiobiological models for predicting tumour control and normal tissue complications. |
| Ethics approval | Hammersmith and Queen Charlotte's and Chelsea Research Ethics Committee approved on the 27th July 2009 (ref: 09/H0707/38) |
| Study design | Phase I/II multicentre interventional study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Non-small cell lung cancer |
| Participants - inclusion criteria |
1. Histologically or cytologically confirmed NSCLC
2. Stages: IIb, IIIa and IIIb (according to International Union Against Cancer Classification of Malignant Tumors [UICC TNM] 7th Edition 2009) 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. |
| Participants - 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 |
| Anticipated start date | 01/12/2009 |
| Anticipated end date | 01/12/2011 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 105 |
| 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 fractions to planning target volume [PTV]) for six weeks given concurrently with standard chemotherapy (2 cycles of cisplatin and vinorelbine). On-treatment assessments: 1. Weekly for 6 weeks Post-treatment assessments: 2. Weekly until 1 month post RT, then 3. Monthly until 6 months post RT, then 4. 3-monthly until 2 years post RT, then 5. 6-monthly until 3 years post RT, then 6. Annually |
| Primary outcome measure(s) |
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. 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. |
| Secondary outcome measure(s) |
Oesophagus:
Chronic oesophageal stricture rate: grade 1 - 5 according to Radiation Therapy Oncology Group (RTOG) late toxicity scales from 3 months post-RT. Lung: 1. Pneumonitis grades 2 - 5 (CTCAE v4.0) 6 or more months after end of RT 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 12 months post-RT |
| Sources of funding | Cancer Research UK (CRUK) (UK) (ref: C13530/A10424) |
| Trial website | |
| Publications | |
| Contact name | Dr David Landau |
| Address |
Guy’s & St. Thomas’ NHS Trust
Lambeth Palace Road |
| City/town | London |
| Zip/Postcode | SE1 7UH |
| Country | United Kingdom |
| Sponsor | University College London (UCL) (UK) |
| Address | Gower Street |
| City/town | London |
| Zip/Postcode | WC1E 6BT |
| Country | United Kingdom |
| Sponsor website: | http://www.ucl.ac.uk/ |
| Date applied | 26/10/2009 |
| Last edited | 01/12/2009 |
| Date ISRCTN assigned | 30/11/2009 |
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| © 2010 ISRCTN unless otherwise stated. | |
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