This is a Prospective, Multicenter, Randomized Controlled study to evaluate Stereotactic Body Radiation Therapy (SBRT) as a potential treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) and has been receiving treatment with a targeted agent such as gefitinib, erlotinib and icotinib.
Full Title of Study: “Maintenance Targeted Therapy With or Without Stereotactic Body Radiation Therapy for Stage IV Non-small Cell Lung Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Trial.”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: October 10, 2020
- Radiation: SBRT+TKI
- Received SBRT after three months after EGFR-TKI treatment
- Drug: TKI
- Received EGFR-TKI treatment
Arms, Groups and Cohorts
- Experimental: SBRT+TKI
- SBRT with photon and dose is 40-50Gy/5F after three months after EGFR-TKI treatment
- Active Comparator: TKI
- Standard EGFR-TKI(Gefitinib, erlotinib or icotinib) Gefitinib: 250mg po Qd Erlotinib: 150mg po Qd Icotinib: 125mg po tid
Clinical Trial Outcome Measures
- Time Frame: 2 years
- progression-free survival
- Time Frame: 3 year
- overall survival
Participating in This Clinical Trial
1. Patients must have biopsy proven metastatic NSCLC (Stage IV).
2. Patients must have received first line chemotherapy, from 4-6 cycles, and achieved stable disease or a partial response.
3. Patients receiving first-line erlotinib, gefitinib, or icotinib for EGFR mutant-positive for 3 months and achieved stable disease, partial response or completely response.
4. Age 18 to 75 years old.
5. Patients must have measurable disease at baseline.
6. The amount of metastatic focus ＜5.
7. ECOG score 0-2
8. Adequate normal organ and marrow function for TKI treatment and radiotherapy.
9. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R)
10. Patients must provide written informed consent to participate in the study.
1. Patients who previously received radiotherapy to the primary site.
2. Patient can't tolerate radiotherapy or targeted therapy;
3. Pregnant or nursing women
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Tongji Hospital
- Wuhan Union Hospital, China
- Provider of Information About this Clinical Study
- Overall Official(s)
- li Zhang, MD,PhD, Principal Investigator, Tongji Hospital
- Overall Contact(s)
- li Zhang, MD,PhD, 02783663407, firstname.lastname@example.org
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