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Late hypofractionated stereotactic radiotherapy combined with TKIs for non-small cell lung cancer with brain metastases

Late hypofractionated stereotactic radiotherapy combined with TKIs for non-small cell lung cancer with brain metastases

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026237
Enrollment
Unknown
Registered
2019-09-28
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-09-30

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 brain metastases

Interventions

Case series:hypofractioned stereotactic radiotherapy

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed NSCLC; brain parenchymal metastases confirmed by enhanced MRI; have no or mild neurological symptoms which can be controlled by corticosteroid and dehydration treatment; 2. EGFR or ALK mutation is positive; 3. EGFR-TKIs or ALK-TKIs were effective for extracranial lesions; 4. ECOG PS 0-2; 5. Aged 18-75 years; 6. Never received brain radiotherapy previously; 7. At least one measurable intracranial lesion according to RECIST criteria; 8. Normal organ function; 9. Serum test of pregnancy should be negative for childbearing age women within 7 days before treatment; all enrolled patients (male or female) should have adequate contraception throughout and within 4 weeks after the treatment; 10. The patient must fully understand and voluntarily sign the informed consent form prior to treatment.

Exclusion criteria

Exclusion criteria: 1. Spinal cord or meninges metastases have been confirmed by MRI or CSF. 2. Patients who had registered in or dropped out of study previously. 3. Pregnant or lactating women. 4. The researcher believes that the subject may not be able to complete the study or comply with the requirements of the study.

Design outcomes

Primary

MeasureTime frame
intracranial PFS;intracranial ORR;

Secondary

MeasureTime frame
PFS;overall survival;

Countries

China

Contacts

Public ContactZhou Lin

West China Hospital, Sichuan University

drzhoulin@163.com+86 18980606671

Outcome results

None listed

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