Non-small Cell Lung Cancer
Conditions
Interventions
experimental group:TKI combined with Stereotactic Body Radiation Therapy
Sponsors
Departmen of Radiation Oncology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Stage IV disease (AJCC Staging system 8th edition); 3. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with EGFR gene mutation; 4. ECOG score was 0-2; 5. Life expectancy >= 6 months. 6. Patients receiving gefitinib, or icotinib or Osimertinib for EGFR mutant-positive for 3 months and achieved stable disease, partial response Within 3 months of initiating their first TKI treatment regimen. Each organ (brain, lung, liver, adrenal gland and vertebral body) was <= 4 metastatic lesions, and at least 1 of them was a measurable lesion. 7. Residual lesions were assessed by a radiation oncologist as suitable for SBRT treatment. 8. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A negative serum or urine pregnancy test within 2 weeks of registration for women of childbearing potential is required. 9. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. CT short diameter of residual hilar or mediastinal lymph nodes > 1 cm. 2. She or he has been targeted with drugs, such as cetuximab, trastuzumab, etc. 3. Other anti-tumor treatments have been carried out for NSCLC, including radiotherapy, research treatment, etc. 4. The upper gastrointestinal physiology is not perfect, or the absorption disorder syndrome, or the oral medicine can not be tolerated, or there is active gastrointestinal ulcer. 5. Patients with other cancers other than NSCLC within 5 years before the start of the study (except for simple surgical resection and disease-free survival for at least 5 consecutive years, cured cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial carcinoma). 6. Patients with small cell lung cancer. 7. Advanced cases of malignant pleural effusion or pericardial effusion alone or stage IV patients without control of malignant pleural effusion or pericardial effusion. 8. There is any clinical evidence indicating moderate or severe COPD, active interstitial lung disease and other active lung diseases determined by the researchers, including primary pulmonary fibrosis. 9. Known allergy to EGFR-TKI or related components. 10. High risk factors such as bleeding, fistula, perforation and so on. 11. Any unstable systemic disease: including active infection, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (NYHA >= grade II), myocardial infarction occurring in the first six months before enrollment, serious arrhythmia requiring drug treatment, liver, kidney or metabolic diseases. 12. Known human immunodeficiency virus (HIV) infection; known active hepatitis B (HBV DNA positive) or hepatitis C. 13. Within 2 weeks before the study, there were active or uncontrollable infections requiring systematic treatment. 14. Being allergic to gadolinium or suffering from claustrophobia or other factors and unable to perform MRI enhancement. 15. Pregnant or lactating women; 16. Other researchers think that they can not complete the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression free survival;ORR(objective response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year Overall survival;2-year local control rate;Adverse events;4. The time of EGFR-T790M mutations;ORR(objective response rate);Quality of life; | — |
Countries
China
Contacts
Public ContactHong Ge
Henan Cancer Hospital
Outcome results
None listed