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Phase I/II study of simuItaneous integrated boost intensity-modulated radiotherapy for brain metastasis

Phase I/II study of simuItaneous integrated boost intensity-modulated radiotherapy for brain metastasis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026794
Enrollment
Unknown
Registered
2019-10-22
Start date
2019-10-28
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

brain metastasis

Interventions

single arm:Radiotherapy

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years, male and female; 2. Pathology confirmed brain metastasis in patients with NSCLC, breast cancer, gastric, intestinal and esophageal cancer, which was confirmed by imaging; 3. Karnofsky Performance Status (KPS)> 50; 4. Normal liver and kidney function and blood routine (within 1.5 times of the upper limit, the lower limit is not lower than the lower limit of the normal value); 5. 2-10 metastases, maximum diameter <5cm; 6. Refuse surgery and stereotactic radiotherapy for single intracranial metastasis (for single intracranial metastasis, surgery and stereotactic radiotherapy are first recommended).

Exclusion criteria

Exclusion criteria: 1. Unable to perform postural fixation and MRI examination; 2. According to the above imaging (CT, MRI) evaluation by the attending physician, the extensive extracranial lesions could not be controlled, and the expected OS was <3 months; 3. According to the above imaging (CT, MRI) evaluation by the attending physician, the large lesion or main lesion within the brainstem was < 4mm away from the brainstem and optic chiasm; 4. Pregnant and breastfeeding women; 5. Drug or alcohol abuse; 6. History of intracranial radiotherapy.

Design outcomes

Primary

MeasureTime frame
control rate of intracranial lesions at 6 months;

Countries

China

Contacts

Public ContactYong Liu

Department of Radiation Oncology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine

drliuyrt@163.com+86 021-37798364

Outcome results

None listed

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