ISoToxic Accelerated RadioTherapy in Locally Advanced Non-small Cell Lung Cancer: The Phase I/II I-START Trial (I-START)
Locally Advanced Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Locally Advanced Non-small Cell Lung Cancer focused on measuring radiotherapy, non small cell lung cancer, isotoxic
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed stage II - IIIb NSCLC (see appendix II)
- Inoperable disease (as assessed by a lung cancer MDT with thoracic surgical input) or operable but the patient refuses surgery
- Disease which can be encompassed within a radical radiotherapy treatment plan in keeping with standard practice at the participating centre
- WHO Performance Status 0 or 1 (Appendix III)
- Adequate respiratory function: FEV1 ≥ 1.0 litre, DLco (transfer factor) ≥ 40% of predicted and Kco (DLco/VA) > 40% predicted on baseline lung function tests
- Blood Haemoglobin ≥ 10g/dL
- No prior thoracic radiotherapy
- Age ≥ 16 years
- Considered fit to receive trial treatment
- Estimated life expectancy of more than 3 months
- Written informed consent obtained
- Patient consents for electronic CT scan and planning data to be used for future research
- Patient is available for follow up
Exclusion Criteria:
- Medically unstable (e.g. unstable diabetes, uncontrolled hypertension, infection, hypercalcaemia or very symptomatic ischaemic heart disease)
- Previous or current malignant disease likely to interfere with protocol treatment
- Pancoast tumours
- Connective tissue disorders (e.g. Scleroderma, Systemic Lupus Erythematosus)
- Interstitial lung disease
- Women who are pregnant or lactating
- Women of childbearing potential who are not using adequate contraceptive precautions
Sites / Locations
- Velindre Cancer Centre
- Clatterbridge Centre for Oncology
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group 1A
Group 1B
Phase II
Group 1A is where less than or equal to 6.5cm length of oesophagus is lying with the Planning Target Volume. Dose will be between 58 and 65Gy determined by current trial cohort in Phase I.
Group 1A is where more than 6.5cm length of oesophagus is lying with the Planning Target Volume. Dose will be between 58 and 65Gy determined by current trial cohort in Phase I.
All patients will receive radiotherapy to a maximum dose of 65Gy in 20 fractions. The dose to the individual patient will be determined by their individual dose constraints for organs at risk.