At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Prophylactic cranial irradiation (radiation)
- How long the study runs
- Study runs about 66 months (dates as stated)
- About the drug or intervention
- Prophylactic cranial irradiation — radiation: Prophylactic cranial irradiation (PCI) is a technique used to combat the occurrence of metastasis to the brain in highly aggressive cancers that commonly metastasize to brain, most notably small-cell lung cancer.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by the European Organisation for Research and Treatment of Cancer (EORTC), is for people with small-cell lung cancer that has not spread to the brain after standard treatment. It compares two approaches: preventive radiotherapy to the brain or regular check-ups using magnetic resonance imaging (MRI) scans to watch for cancer spreading to the brain.
Who can take part
- Adults aged 18 or over with a confirmed diagnosis of small-cell lung cancer, at limited or extensive stage
- Have finished standard treatment (chemotherapy, with or without radiotherapy or surgery) with no sign that the cancer has grown
- No cancer spread to the brain or the tissues around it, confirmed by scans within 28 days before joining
- Joining within 8 weeks of the last cycle of chemotherapy
- Able to carry out day-to-day activities with little or some help (performance status score of 2 or below)
- Kidney function good enough (creatinine clearance of at least 30 mL/min)
- If able to become pregnant, a negative pregnancy test and use of highly effective contraception during treatment and for 30 days after; breastfeeding must stop before treatment starts
- Willing and able to attend study visits and follow-up, and to give written informed consent
Who may not be able to
- Previous radiotherapy to the brain or whole brain (some exceptions for past targeted radiosurgery for non-cancerous conditions may be considered case by case)
- Allergy or other reaction to MRI contrast dye or tracers, or inability to have an MRI (for example, metal implants)
- Another cancer needing treatment now
- Ongoing side effects from previous treatment that are worse than mild at the time of joining
- Serious health problems, such as heart attack or unstable angina in the past 6 months, serious liver disease, or an infection needing treatment at the time of joining
- HIV with a CD4 count below 200 cells per microlitre (people with HIV on treatment and a CD4 count of 200 or above may join)
- Severe neurological or mental health conditions needing treatment, such as dementia or epilepsy
- Any personal, family or living situation that might make it hard to follow the study schedule
What taking part involves
- • Being placed by chance (randomised) into one of two groups: preventive radiotherapy to the brain, or active monitoring with regular MRI scans
- • Regular MRI scans of the brain and scans of the chest, abdomen and pelvis (computed tomography (CT) or MRI)
- • Follow-up visits and examinations throughout the study
Time commitment: Taking part involves attending scheduled visits, having treatment (if in the radiotherapy group) and regular MRI scans and check-ups for the whole study period — exact number of visits and total duration: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 600
- Started
- 2022-10-27
- Last checked
- 2023-11
Plain English Summary
What is this study?
- • Testing a new treatment for limited stage small cell lung cancer
- • NA - 600 participants
- • In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with limited stage small cell lung cancer
Where?
- • Bristol - University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
- • Edinburgh - NHS Lothian - Western General Hospital
- • Maidstone - Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital
- • Manchester - The Christie NHS Foundation Trust
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.
More detail
The primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population under the treatment policy strategy. The secondary objectives are: * To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of cognitive failure free survival (CFFS) compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. * To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of global health status/QoL and cognitive functioning according to EORTC QLQ-C30 questionnaire compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. * To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the two arms in the treated population (i.e. patients who have started treatment). The exploratory objectives are: * To compare OS and CFFS between the arms within the subgroups of patients with LS and ES disease. * To compare OS and CFFS between the arms within the subgroups: HA-PCI or not, first-line immunotherapy or not, memantine or not. * To compare cognitive failure free survival (CFFS) rate at 12 months after randomization between the arms. * To compare the cumulative incidence of cognitive failures with death as a competing risk between the arms. * To compare brain-metastasis-free survival (BMFS) between the arms. * To compare progression free survival (PFS) between the arms. * To compare time to brain-metastasis-attributed death (TBMAD) between the arms. * To compare other QoL scales according to EORTC QLQ-C30 and QLQ-BN20 questionnaires between arms. * To evaluate the cost-effectiveness of MRI surveillance alone versus MRI surveillance combined with PCI. * To collect blood for biobanking.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a negative serum pregnancy test within 3 days
What the study is looking for
- ✓Age ≥ 18 years
- ✓Histologically/cytologically proven diagnosis of SCLC
- ✓Limited and extensive stage
- ✓ES SCLC: Stage IV (T any, N any, M 1a/b), or T3-4 due to multiple lung nodules that are too extensive or have...
- ✓Completed standard therapy prior to randomization:
Who cannot take part
- ✗Other active blood or solid tumour cancer requiring current active treatment.
- ✗Any unresolved toxicities from prior therapy (e.g., drug treatment, radiotherapy) greater than CTCAE grade 2...
- ✗Patient with severe active other health conditions, defined as follows:
- ✗Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to randomization
- ✗Transmural myocardial infarction within 6 months prior to randomization
See the full criteria
Where Is This Study? (7 UK sites)
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre
Bristol BS2 8ED, United Kingdom
NHS Lothian - Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital
Maidstone ME16 9QQ, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham NG5 1PB, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital
Sheffield S10 2SJ, United Kingdom
Royal Marsden Hospital - Sutton
Sutton SM2 5PT, United Kingdom
How to Get in Touch
EORTC Reception
Sponsor contactCONTACT
