A randomized, controlled trial for comparing efficacy and safety of simultaneous-integrated boost intensity-modulated radiotherapy versus whole-brain radiotherapy in multiple brain metastatic non-small cell lung cancer patients with negative diver gene

A randomized, controlled trial for comparing efficacy and safety of simultaneous-integrated boost intensity-modulated radiotherapy versus whole-brain radiotherapy in multiple brain metastatic non-small cell lung cancer patients with negative diver gene.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800017803

Enrollment

Unknown

Registered

2018-08-15

Start date

2018-09-01

Completion date

Unknown

Last updated

2018-08-20

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

Conditions

multiple brain metastatic non-small cell lung cancer patients with negative diver gene

Interventions

experimental group:simultaneous-integrated boost intensity-modulated radiotherapy, PGVT50-54Gy/10-12f, PCTV 30Gy/10-12f

hippocampus protecting

control group:whole brain radiotherapy, PCTV30Gy/10f

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed EGFR negative NSCLC within 5 years, and =4 evaluable brain metastases confirmed by enhanced MRI which was assessed to be unsuitable for SRS, gamma knife nor skull X - knife treatment; 2. More than 3 months expected survival time ( or RPA I-II); 3. KPS score > 70; Or lower KPS score can be improved by symptomatic treatment such as dehydration (the reduction of KPS score was caused by intracranial metastasis, which was evaluated by the researchers).

Exclusion criteria

Exclusion criteria: 1. Patients who have received whole brain radiotherapy, gamma knife, head knife and other head radiotherapy or already included in other studies. 2. Patients accompanied by other malignant cancers and which would affect the expecting survival. 3. Orally take temozolomide during radiotherapy. 4. Accepting surgical resection of brain metastases and no target lesion left to be evaluated. 5. Leptomeningeal Metastases; 6. Accepting EGFR, ALK or ROS-1 TKIs or immunotherapy. 7. Concomitant spirit, nerve disorders which cannot cooperate with radiation. 8. Any contraindications to enhanced MRI and CT examination. 9. Previous head radiotherapy.

Design outcomes

Primary

Measure	Time frame
Intracranial progression-free survival time;intracranial control rate of 6 months;intracranial control rate of 12 months;Overall survival;	—

Secondary

Measure	Time frame
Quality of life of Cognitive-behavior;Incidence of treatment-related side effects;Incidence of treatment-related side effects;	—

Countries

China

Contacts

Public ContactGuanghui LI

Department of radiation oncology, Second Affiliated Hospital of Army Military Medical University

liguanghui_2000@aliyun.com+86 13996181950

Outcome results

None listed

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