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.