A Phase I/II Trial of Isotoxic Accelerated Radiotherapy in the Treatment of Patients With Non-small Cell Lung Cancer
Main inclusion criteria:
1. Histologically or cytologically confirmed stage II - IIIb NSCLC (see appendix II)
2. Inoperable disease (as assessed by a lung cancer MDT with thoracic surgical input) or
operable but the patient refuses surgery
3. Disease which can be encompassed within a radical radiotherapy treatment plan in
keeping with standard practice at the participating centre
4. WHO Performance Status 0 or 1 (Appendix III)
5. Adequate respiratory function: FEV1 ≥ 1.0 litre, DLco (transfer factor) ≥ 40% of
predicted and Kco (DLco/VA) > 40% predicted on baseline lung function tests
6. Blood Haemoglobin ≥ 10g/dL
7. No prior thoracic radiotherapy
8. Age ≥ 16 years
9. Considered fit to receive trial treatment
10. Estimated life expectancy of more than 3 months
11. Written informed consent obtained
12. Patient consents for electronic CT scan and planning data to be used for future
research
Main exclusion criteria:
1. Medically unstable (e.g. unstable diabetes, uncontrolled hypertension, infection,
hypercalcaemia or very symptomatic ischaemic heart disease)
2. Previous or current malignant disease likely to interfere with protocol treatment
3. Pancoast tumours
4. Connective tissue disorders (e.g. Scleroderma, Systemic Lupus Erythematosus)
5. Interstitial lung disease
6. Women who are pregnant or lactating
7. Women of childbearing potential who are not using adequate contraceptive precautions
Primary outcome measure:
Phase I:
• Establish the maximum tolerated dose (MTD) to the oesophagus to use as the
recommended Phase II dose.
Phase II:
• Toxicity rate (grade 3 and 4) at three months.
Secondary outcome measures
Phase I:
• Chronic oesophagitis or stricture occurring/persisting two months or more after
completion of radiotherapy
Phase II:
- Local control at three months (to include complete response, partial response and
stable disease)
- Feasibility
- Time to Local Progression; measured in days from the day of trial entry to the
date of first clinical evidence of progressive disease at the primary site
- Time to distant metastases measured in days
- Overall Survival; measured in days, from the day of trial entry to the day of
death (from any cause)
- Toxicity; pulmonary, oesophageal, spinal cord and cardiac grade 3 or 4 toxicity
occurring up to three months after radiotherapy
- Radiotherapy Quality Assurance. A detailed QA program will be in place to ensure
adherence to the protocol. Major and minor deviations will be documented
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: Establish the maximum tolerated dose (MTD) to the oesophagus to use as the recommended Phase II dose.
toxicity assessed up to 60 days after last Radiotherapy dose
No
Jason Lester, MBBS, MRCP, FRCR
Principal Investigator
Velindre Cancer Centre
United Kingdom: Research Ethics Committee
2009/VCC/0080
NCT01537991
January 2012
December 2013
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