Stage IV advanced lung cancer Cancer Malignant neoplasm of bronchus and lung
Conditions
Interventions
RAMON is a pragmatic, multi-centre randomised controlled trial (RCT) in NHS hospitals, with an internal pilot phase and active follow-up for a minimum of 2 years. The full RCT will evaluate the accept
Sponsors
Royal Brompton Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. 18 years of age or over 2. Tissue confirmed non-small cell lung cancer pre-treatment clinical stage IV 3. Lung cancer treatment naïve prior to initial study systemic anti-cancer treatment 4. Completed standard of care systemic anti-cancer treatment 5. Performance status 0 (i.e. asymptomatic) or performance status 1 (i.e. symptomatic but completely ambulatory) as per Eastern Cooperative Oncology Group (ECOG) definitions 6. LCT eligible disease, defined as all disease sites amenable to radical treatment (e.g. surgery, radiotherapy or ablation)
Exclusion criteria
Exclusion criteria: 1. Serious concomitant disorder that would compromise patient safety during LCT 2. Complications from initial systemic anti-cancer treatment that precludes maintenance systemic anti-cancer treatment 3. Patient unable/unwilling to adhere to study procedures 4. Patient unable to give written informed consent 5. Women who are pregnant or breast feeding 6. Co-enrolment in another trial if either: interventional trial that aims to improve survival, not permitted by other trial, would result in too much patient burden
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival, defined as date of randomisation to death from any cause (minimum follow-up 2 years after randomisation) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease progression-free survival (PFS), defined as the time from randomisation to documented disease progression, as evaluated by local site radiologist from CT or PET/CT scan (e.g. CT of the head, chest, abdomen, pelvis and other anatomical sites); bone scan or MRI, carried out as part of the patients’ standard care (minimum follow-up 2 years after randomisation) or death from any cause 2. Serious adverse health events recorded using safety reporting processes and data collection forms from randomisation to the end of the study (minimum of 2 years) 3. Patient-reported HRQoL measured using the European Organisation For Research and Treatment of Cancer’s Quality of Life Questionnaire-C30 (EORTC QLQ-C30) from randomisation to the end of the study (minimum of 2 years) 4. Health-related quality of life measured using the European Organisation For Research and Treatment of Cancer’s Quality of Life Questionnaire-LC13 (EORTC QLQLC13) to the end of the study (minimum of 2 years) 5. Health-related quality of life measured using the EQ-5D-5L questionnaire (EuroQol EQ-5D-5L) to the end of the study (minimum of 2 years) | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactChloe Beard
Outcome results
None listed