Quality of life after radiotherapy treatment for patients with non-small cell lung cancer
| ISRCTN | ISRCTN52137148 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52137148 |
| IRAS number | 334993 |
| Secondary identifying numbers | CPMS 62639, NIHR133518, IRAS 334993 |
- Submission date
- 29/07/2024
- Registration date
- 19/08/2024
- Last edited
- 08/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Radiotherapy of the chest area is widely used in the treatment of lung cancer. Its use in stage IV NSCLC has evolved across the world based on local experience, as doctors attempt to ease symptoms, maintain/improve quality of life, and prolong survival while minimising side effects. The way this type of radiotherapy is given is based on limited and dated evidence with many variations, and there is a need for new research to figure out the best use of radiotherapy, including timing and dosage.
This new research is also needed because radiotherapy machines and radiotherapy delivery techniques have improved and become more effective. The aims of QUARTZ LUNG are:
- to work out the effect that low-dose radiotherapy to the chest has on symptoms, length and quality of life.
- to assess the side effects and safety of low-dose radiotherapy in the chest area
- to work out the cost-effectiveness of this type of radiotherapy
- to identify potential barriers, evaluate and explain the treatment and outcomes, and highlight issues from a patient, carer, and health care professional’s point of view.
Who can participate?
Patients aged 16 years and older, with stage IV NSCLC. Not receiving chemotherapy or other systemic treatments, fit enough to receive low-dose radiotherapy to the chest area and without symptoms requiring immediate radiotherapy. The trial is taking place at approximately 36 NHS sites throughout the UK and aims to enrol a total of 448 participants.
What does the study involve?
Following consent, patients will undergo screening tests to ensure they are eligible. Once screened eligible, patients are randomly allocated to one of the two treatment groups. The two treatment groups are:
Control Arm: supportive and palliative care based on your symptoms
Radiotherapy Arm: supportive and palliative care based on your symptoms AND radiotherapy that will start no later than 3 weeks after allocation.
A patient is just as likely to receive either of the treatment groups. If allocated to the radiotherapy arm, patients will have a radiotherapy planning session with a CT scan.
Patients will attend usual clinic visits, or if unable to attend a member of the research team will contact them by telephone at weeks 0-2, week 3, week 4, week 5, week 6, week 8, month 3, month 4, month 5, month 6 for study assessments. The study assessments will vary depending on the visit but can include weight, asking about how the patient has been feeling and any health issues, asking about any changes to medication and level of self-care/daily activity/physical ability, and completing questionnaires.
What are the possible benefits and risks of participating?
Possible benefits:
- There may or may not be a direct medical benefit from taking part in the trial.
- This will help to further our knowledge of how to best use radiotherapy for stage IV NSCLC and this may benefit others with the same condition in the future.
Possible risks/disadvantages:
- There may be some unpleasant side effects.
- There could be risks to your child if you become pregnant, or breastfeeding.
- Patients may have a CT scan of their brain during screening but only if it is a standard assessment at the hospital they are being treated in. They will also have a chest/abdomen/pelvis CT scan at screening unless one has been done recently.
- Patients allocated to the radiotherapy arm will have a radiotherapy planning session with a CT scan. This is the standard of care for patients receiving radiotherapy.
CT scans and radiotherapy use ionising radiation that may cause cancer many years or decades after exposure. The chance of cancer being caused by ionising radiation associated with imaging or radiotherapy is very small in these patients.
Where is the study run from?
The Christie NHS Foundation Trust
When is the study starting and how long is it expected to run for?
April 2023 to December 2027
Who is funding the study?
NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC)
Who is the main contact?
tourist-quartzlung@soton.ac.uk
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-quality-of-life-after-radiotherapy-for-advanced-non-small-cell-lung-cancer-quartz
Contact information
Public, Scientific
Southampton Clinical Trials Unit, MP131, Southampton General Hospital, Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 8120 5154 |
|---|---|
| tourist-quartzlung@soton.ac.uk |
Study information
| Study design | Randomized parallel-group controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | QUARTZ LUNG: Quality of life after radiotherapy treatment for patients with stage IV non-small cell lung cancer |
| Study acronym | QUARTZ LUNG (TOURIST Platform) |
| Study hypothesis | The QUARTZ LUNG trial will test the hypothesis that early low-dose palliative thoracic radiotherapy is clinically effective in health utility for patients with stage IV non-small cell lung cancer. |
| Ethics approval(s) |
Approved 07/05/2024, South Central - Oxford C Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 1048144, 207 104 8089, 207 104 8271; oxfordc.rec@hra.nhs.uk), ref: 24/SC/0133 |
| Condition | Stage IV non-small cell lung cancer |
| Intervention | 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 randomisation and minimise treatment delays potentially eligible patients should be identified as soon as possible after the diagnosis of stage IV NSCLC is made. Patients eligible for QUARTZ LUNG may not otherwise meet an oncologist and it is therefore crucial that this cohort are identified by their usual care team or at the thoracic multidisciplinary team meeting. Early low-dose radiotherapy is added as a treatment for patients with stage IV NSCLC who are not receiving systemic treatment. This study seeks to establish the role of low-dose thoracic palliative for this patient population. Patients will be randomised (1:1) to the addition of thoracic radiotherapy to symptomatic palliative care. Once written informed consent has been gained, all screening and baseline procedures have been completed and the patient is confirmed eligible, they will be randomised (1:1) to one of two study arms: Control Arm – symptom-based supportive and palliative care, Radiotherapy Arm - symptom-based supportive and palliative care and radiotherapy. Patients will have equal chances of receiving one of the two arms. There will be either 2 or 5 visits for radiotherapy, depending on the clinician's decision. Radiotherapy will begin as soon as possible after randomisation, no later than 21 days after randomisation. Patients will be followed up to Month 6, follow-up assessments include: - weight - ECOG performance status - adverse event, toxicity and medication assessment - quality of life questionnaires - smoking habits questions When all patients have completed all of their study visits, survival data will be collected directly from the hospital sites. An economic evaluation to measure the quality-adjusted life years at 6 months will be performed. A process evaluation using interviews (over the phone or using an online meeting system (eg. Zoom) and a PPI questionnaire to identify issues for implementation from patients, patient carers and Health Care Professionals. - 15 patients - individual interview - All patients - PPI QoL questionnaire completion - 15 patient-carers - individual interview - 10 Health Care Professionals (across 2 trials in the TOURIST Platform) - individual interview. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/04/2023 |
| Overall study end date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 448; UK Sample Size: 448 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 24/07/2024 |
| Recruitment end date | 30/06/2027 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Nottingham
NG5 1PB
United Kingdom
Sutton-in-Ashfield
NG17 4JL
United Kingdom
Sheffield
S10 2SB
United Kingdom
Crewe
CW1 4QJ
United Kingdom
Wolverhampton
WV10 0QP
United Kingdom
Exeter
EX2 5DW
United Kingdom
Manchester
M20 4BX
United Kingdom
Rom Valley Way
Romford, Essex
RM7 0AG
United Kingdom
Shrewsbury
SY3 8XQ
United Kingdom
Liverpool
L7 8YA
United Kingdom
Colchester
CO4 5JL
United Kingdom
Guildford
GU2 7XX
United Kingdom
London
NW1 2PG
United Kingdom
Lothian
EH4 2LF
United Kingdom
Dumfries
Dumfries and Galloway
DG1 4AP
United Kingdom
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Southampton
SO16 6YD
United Kingdom
Bristol
BS2 8ED
United Kingdom
Sponsor information
Hospital/treatment centre
550 Wilmslow Road
Withington
Manchester
M20 4BX
England
United Kingdom
| the-christie.sponsoredresearch@nhs.net | |
| Website | https://www.christie.nhs.uk/ |
"ROR" |
https://ror.org/03v9efr22 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data-sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
08/04/2025: The following changes were made:
1. The Sheffield Teaching Hospitals NHS Foundation Trust study participating centre was replaced with Weston Park Hospital.
2. Royal Devon University Healthcare NHS Foundation Trust, The Christie NHS Foundation Trust, and Barking, Havering and Redbridge University Hospitals NHS Trust were removed from the study participating centres.
3. The Royal Devon and Exeter Hospital, The Christie Hospital, Queen's Hospital, Royal Shrewsbury Hospital, Clatterbridge Cancer Centre, Colchester Hospital, Royal Surrey County Hospital, University College London Hospital, Edinburgh Cancer Centre, Dumfries and Galloway Royal Infirmary, Guy's and St Thomas' Hospital, Southampton General Hospital, and Bristol Haematology and Oncology Centre were added as study participating centres, and Scotland was added to the Countries of recruitment.
27/01/2025: Cancer Research UK plain English summary link added to plain English summary field.
24/10/2024: The following changes were made:
1. Weston Park Hospital was removed from the study participating centres.
2. Sheffield Teaching Hospitals NHS Foundation Trust, Royal Devon University Healthcare NHS Foundation Trust, The Christie NHS Foundation Trust, Leighton Hospital, Barking, Havering and Redbridge University Hospitals NHS Foundation Trust and New Cross Hospital were added as study participating centres.
29/07/2024: Study's existence confirmed by the NIHR.
