Stage III Non-Small Cell Lung Cancer Cancer Stage III Non-Small Cell Lung Cancer
Conditions
Interventions
Minimisation incorporating a random factor will be used to allocate patients between treatment arms A:B:C:D:E so that an overall study ratio of 2:1:1:1:1 is achieved. Patients will only be randomised
Sponsors
NHS Greater Glasgow & Clyde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed stage III NSCLC 2. Performance status (PS) – ECOG 0-2 Patients with PS 2 can only be included if the local investigator deems the general condition is explained by disease or the primary chemotherapy treatment 3. Inoperable disease, unsuitable for concurrent chemo-radiotherapy, in the opinion of the treating Oncologist 4. Patients who have had a complete response, partial response or stable disease on CT assessment after 2 cycles of platinum based chemotherapy 5. Willing and able to give written informed consent 6. Aged 16 or over 7. Adequate PFT results: FEV1 and/or KCO = 40% of predicted
Exclusion criteria
Exclusion criteria: 1. Previous or current malignant disease likely to interfere with the protocol treatment or comparisons 2. Medically unstable (unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcaemia, ischaemic heart disease) 3. Connective tissue disorders (Scleroderma, Systemic Lupus Erythematosus) 4. Clinically significant interstitial lung disease 5. History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol 6. Pregnant or lactating women 7. Any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) is determined via RECIST reporting of scans performed at disease evaluation visits during follow-up at months 3, 6, 12, 18, 24 and 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival (OS) is measured by collecting survival status at each follow up visit (months 2, 3, 4, 6, 9, 12, 15, 18, 21, 24, 36 and annually until the end of the study period (June 2021)). Cause of death and evidence for cause of death will be recorded by participating sites, and is collected from cancer centres, cancer registries and national databases. 2. Time to local-regional failure is determined via RECIST reporting of scans performed at disease evaluation visits during follow-up at months 3, 6, 12, 18, 24 and 36 months 3. Toxicity as assessed by NCI CTCAE v4.03 during treatment and during follow-up at months 3, 6, 12, 18, 24, 36 months and annually until end of study 4. Cost Effectiveness is based on quality adjusted life years calculated using resource-use data (delivery of radiotherapy, hospital inpatient/outpatient/high dependency days) and quality of life (EQ-5D) measured during treatment and follow-up (months 2, 3, 4, 6, 9, 12, 15, 18, 21, 24, 36 and annually until end of study) | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactClaire Lawless
Outcome results
None listed