A phase III multi-centre randomised controlled trial to assess whether optimal supportive care alone (including dexamethasone) is as effective as optimal supportive care (including dexamethasone) plus whole brain radiotherapy in the treatment of patients with inoperable brain metastases from non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13826061

Enrollment

534

Registered

2006-09-22

Start date

2007-03-02

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer with inoperable brain metastases Cancer Lung cancer

Interventions

Optimal supportive care (OSC, including dexamethasone) alone versus OSC and whole brain radiotherapy (WBRT).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically proven primary NSCLC 2. Computed tomography (CT)/magnetic resonance imaging (MRI) confirming brain metastases 3. Inoperable brain metastases as assessed by a lung cancer Multi-Disciplinary Team (MDT) or patients for whom surgery is deemed inappropriate 4. Clinician and patient uncertain of the role of whole brain radiotherapy (WBRT) 5. Patient able and willing to respond to questions in a weekly telephone assessment 6. Patient able and willing to give informed consent 7. Aged over 18 years 8. Baseline patient assessment form completed

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 14/01/2014: 1. Clinician and/or patient certain that WBRT will be of benefit 2. Clinician and/or patient certain that WBRT will not be of benefit 3. Previous or current illness, which has not been brought under control and/or is likely to interfere with protocol treatment or comparisons 4. Chemotherapy (last cycle) within 3 weeks prior to randomisation 5. Previous radiotherapy to the brain 6. Surgery for brain metastases within one month prior to randomisation Previous exclusion criteria: 1. Clinician and/or patient certain that WBRT will be of benefit 2. Clinician and/or patient certain that WBRT will not be of benefit 3. Previous or current illness, which has not been brought under control and/or is likely to interfere with protocol treatment or comparisons 4. Estimated glomerular filtration rate (EGFR) inhibitors within one week prior to randomisation 5. Chemotherapy (last cycle) within one month prior to randomisation 6. Previous radiotherapy to the brain 7. Surgery for brain metastases within one month prior to randomisation

Design outcomes

Primary

Measure	Time frame
Quality-adjusted life-years. Follow-up is weekly until 12 weeks, then 4 weekly, until death.	—

Secondary

Measure	Time frame
1. Overall survival 2. Karnofsky Performance Status 3. Patient symptoms Follow-up is weekly until 12 weeks, then 4 weekly, until death.	—

Countries

Australia, England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026