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Trial Details
Trial status:
Closed
Recruitment start date:
01/12/2009
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Dr David Landau
Recruitment target:
105
EudraCT number:
Contact details:
ctc.ideal-crt@ucl.ac.uk
Lay summary:
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
Description
Design: IDEAL-CRT is a multicentre phase I/II trial of concurrent chemoradiation with dose-escalated radiotherapy in patients with stage II or stage III Non-Small Cell Lung Cancer. 
Treatment:
The method of dose escalation will be through an individual patient-based model. Each patient will be treated to the dose that, based on the optimised distribution of radiation of his/her treatment plan, is calculated to be associated with an acceptable level of grade three toxicity (from oesophagus or lung).

5 Week Protocol: 30 single daily fractions to Planning Target Volume (PTV) for five weeks with one day per week twice daily (bd) Concurrent treatment with cisplatin and vinorelbine on days 1 and 8 (vin only), and days 22 and 29 (vin only).

6 Week Protocol: 30 single daily fractions to Planning Target Volume (PTV) for six weeks. Concurrent treatment with cisplatin and vinorelbine on Days 1 and 8 (vin only), and Days 29 and 36 (vin only). 

Key inclusion/exclusion criteria: Patients must have histologically or cytologically confirmed NSCLC, stages: IIa, IIb, IIIa and IIIb (UICC TNM 7th Ed. 09), WHO Performance status 0 or 1, life expectancy > 6 months and Radiotherapy dose constraints consistent with minimum prescription dose of 63Gy in 30 fractions. Patients cannot have Tumours with a rNTDmeancorr of >0.30, or 30% of the ipsilateral brachial plexus receiving more than 60Gy. 
Duration of recruitment: Recruitment was completed 31st March 2015. The end of trial is 24 months post radiotherapy for last patient recruited (to the 5 week protocol).
Aim
Main Trial: To investigate the toxicity, feasibility and potential clinical effectiveness of dose-escalated RT with concurrent chemotherapy in stage II or stage III NSCLC as a potential experimental arm in future phase III trials. 
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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