Non-small Cell Lung Cancer With Brain Metastases
Conditions
Interventions
Experimental group: TMZ+WBRT:Concurrent TMZ same as control group. While concurrent TMZ at 75mg/m2, patients administered orally from the first to the last day of RT and adjuvant TMZ at 200mg/m2 per d
Control group: WBRT:Whole brain radiotherapy of 30Gy/10f by IMRT (Intensity Modulation Radiated Therapy), with simultaneous integrated boost to 40-50Gy/10f. The maximum dose of hippocampus should be n
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Primary lesion was non-small cell lung cancer diagnosed by pathology or cytologyand =1 newly diagnosed brain metastases confirmed by brain MRI or CT after treatment of primary tumor; 2. Extracranial lesions, including primary or recurrent lung tumors, were all under control (CR/PR at least 2 months); no other extracranial metastases or extracranial metastases achieved CR/PR for at least 2 months after treatment (if there were bone metastasesthe period of pain relief and imaging stable should reach at least 2 months); 3. At least one brain metastases =1cm; 4. No endocranium/leptomeninges metastases; 5. =18 years old; 6. KPS=60; 7. No previous brain radiotherapy; 8. No previous TMZ treatment; 9. Without dysfunction of heart, lung, liver, kidney and hematopoiesis; 10. Patients has recovered form previous chemotherapy; 11. Patients who are in reproductive age (including women and male patients) must adopt effective birth control measures; 12. Sign up informed consent.
Exclusion criteria
Exclusion criteria: 1) Other type of primary tumor; 2) Brain metastases appeared at first visit; 3) The primary lesions were not under control; 4) Find extracranial metastases simultaneously; 5) Previous extracranial metastases were not under control; 6) Previous brain radiotherapy; 7) Patients participated in un-terminated clinical trials of other drugs; 8) Patient with a history of serious allergies; 9) Pregnant or lactating women; 10) Uncontrollable active infection; 11) Dysfunction of heart, lung, liver, kidney or hematopoiesis; 12) History of alcohol or drug abuse, continuous vomiting that could interfere with the oral administration of TMZ; 13) Other unsuitable reason;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Overall Survival;Overall Survival Rate at 1 year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate of brain metastases;Time to brain recurrence including both local recurrence and distant recurrence in the brain;The tolerance of TMZ adverse effects;Remission rate of neurological symptoms;Change of neurocognitive function; | — |
Countries
China
Contacts
Public ContactWu Shaoxiong
Department of Radiation Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine
Outcome results
None listed