Stage IV non-small cell lung cancer Cancer
Conditions
Interventions
QUARTZ LUNG is a randomised control trial in the TOURIST Platform. Patients may be identified at any point after the diagnosis of stage IV NSCLC by their usual care team. To permit timely randomisatio
Sponsors
The Christie NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =16 years of age 2. Stage IV NSCLC (radiological diagnosis confirmed at MDT as a minimum) 3. Thoracic disease amenable to radiotherapy 4. Provision of written informed consent 5. For women of childbearing potential: a negative urine or serum pregnancy test within 7 days prior to the randomisation 6. Patients not having systemic treatment 7. ECOG Performance Status 0-3 8. At least T2 and/or N1 disease 9. Fit to receive low-dose palliative radiotherapy according to local guidelines and assessment
Exclusion criteria
Exclusion criteria: 1. The need for palliative radiotherapy to the thorax prior to randomisation 2. Comorbidities which are considered a contraindication to radiotherapy by the treating clinical team, including interstitial lung disease and active connective tissue disorders 3. History of prior malignant tumours likely to interfere with the protocol treatment or comparisons 4. Leptomeningeal disease 5. Women who are pregnant or breastfeeding 6. Women of child-bearing potential who are not able or unwilling to use a highly effective method of contraception 7. Patients who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol 8. Patients receiving systemic therapy for NSCLC 9. Prior treatments for this NSCLC 10. Patients participating in a clinical trial of an investigational medicinal product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health utility measured using EORTC QLU-C10D Area Under the Curve (AUC; using trapezoidal rule) to derive a health utility score per year. Questionnaire completed: Screening/Baseline, week 0-2, week 3, week 4, week 5, week 6, week 8, month 3, month 4, month 5, month 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival - Defined as time from randomisation to death from any cause. Censored at the last follow-up if event-free. 2. Quality of life using EORTC QLQ-C30 and EQ-5D-5L. Questionnaires completed: Screening/Baseline, month 3, month 6. 3. Lung cancer symptoms using EORTC QLQ-LC13. Questionnaires completed: Screening/Baseline, month 3, month 6. 4. Acute and late toxicity as assessed NCI CTCAE v5.0. From informed consent to end of study. | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactSiva Saranya
Outcome results
None listed