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Radiotherapy combined with temozolomide (Tai dao) in the treatment of brain metastasis of non-small cell lung cancer: a multicenter randomized controlled trial

Radiotherapy combined with temozolomide (Tai dao) in the treatment of brain metastasis of non-small cell lung cancer: a multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016291
Enrollment
Unknown
Registered
2018-05-24
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-05-28

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

Conditions

Lung cancer with brain metastasis

Interventions

TMZ group:Temozolomide combined with whole brain radiation therapy
RT group:Whole brain radiation therapy

Sponsors

The first hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old, male or female; 2. Non-small cell lung cancer confirmed by pathological histology of primary lung lesions; 3. Enhanced MRI imaging to diagnose brain metastases, there are measurable brain metastases (RECIST version 1.1), brain metastases = 4; 4. No chemotherapy and participation in other clinical studies within 4 weeks before participating in this study; 5. The ECOG performance status is 0-1, and the expected survival time is = 6 months; 6. The laboratory tests meet the following requirements: WBC = 4.0×10^9/L, neutrophil count = 2.0×10^9/L, PLT = 100×10^9/L HB =100g/L (in the absence of blood transfusion); total bilirubin, ALT, AST = 1.5 times the upper limit of normal; serum creatinine = upper limit of normal value (creatinine clearance =65ml/min); normal ECG; 7. Voluntary Sign the treatment consent form.

Exclusion criteria

Exclusion criteria: 1. Cannot complete the designated pretreatment assessor; 2. The pathological findings of lung primary biopsy were small cell lung cancer or no pathological biopsy results; 3. Treated with EGFR targeted drugs; 4. Can not tolerate brain radiotherapy such as brain metastases with bleeding, etc; 5. Allergic to temozolomide; 6. Pregnancy (confirmed by urine/blood test), breastfeeding women; 7. With uncontrolled diabetes, hypertension, and severe cardiovascular or pulmonary disease; 8. Other circumstances that the researcher considers inappropriate.

Design outcomes

Primary

MeasureTime frame
blood routine examination;Liver and kidney function;ECG;imaging examination;

Countries

China

Contacts

Public ContactGuang Li

The first hospital of China Medical University

13804058616@163.com+86 13804058616

Outcome results

None listed

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