Lung cancer radiation trial halted early – only 6 patients enrolled

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 years of age 2. ECOG (European Cooperative Oncology Group) performance status 0-2 (0-1 for concurrent chemotherapy) 3. Weight loss \<10% within 3 months of diagnosis 4. Histological diagnosis (biopsy or cytology) of NSCLC (Squamous Cell Carcinoma (SCC), Adenocarcinoma, Large Cell). Eligible NSCLC stages: IIA (provided N1); IIB (including T3N0 if unresectable or unsuitable for stereotactic ablative body radiation therapy (SABR)); IIIA and IIIB 5. Inoperable (as per Multi-Disciplinary Team (MDT)) or patient refuses surgery 6. Respiratory function: Forced Expiratory Volume (FEV1) ≥ 1L or ≥ 40% of predicted Diffusing Capacity of Lung for Carbon Monoxide (DLCO) ≥ 40% 7. Radiological confirmation of disease via a Positron Emission Tomography (PET) scan prior to registration. 8. Life expectancy, from causes other than lung cancer, of greater than 12 months (as per physician's opinion) 9. Females of child bearing potential (see Appendix H) must not be pregnant and must be prepared to use adequate contraception methods during treatment. Males whose female partners are of child-bearing potential must be prepared to use adequate contraception methods during treatment. Examples of effective contraception methods are a condom or a diaphragm with spermicidal jelly, or oral, injectable or implanted birth control. 10. Provision of written consent in line with ICH-GCP guidelines Exclusion Criteria: 1. Previous thoracic radiation therapy 2. Known co-existing or prior malignancy which is likely to interfere with treatment or assessment of outcomes 3. Known distant metastases or metastatic pleural effusion 4. Pancoast tumours (tumour of the pulmonary apex) 5. Supraclavicular nodal involvement 6. Spinal cord involvement 7. Patients with syndromes or conditions associated with increased radiosensitivity or development of lung fibrosis 8. Suitable for SABR 9. Idiopathic pulmonary fibrosis/usual interstitial pneumonia 10. Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes 11. Psychiatric illness/social situations that would limit compliance with study requirements 12. Pregnant or lactating at the time of proposed randomisation 13. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study, or if it is felt by the research / medical team that the patient may not be able to comply with the protocol