In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.
Tyrosine kinase inhibitor (TKI) has been widely accepted as the first-line therapy for stage IV NSCLC with active mutation of EGFR. Olio-metastasis is a disease status between localized and extended status of disease, namely with the limited number of lesions, which is generally defined as ≤ 5. A couple of phase II studies have shown that consolidation local management was able to prolong the local-regional tumor control and might further improve overall survival (OS) for oligo-metastatic NSCLC who have gained disease control from systemic therapy. However, there is lack of data regarding whether local radiotherapy (RT) could improve progression free survival (PFS) and OS for NSCLC with active EGFR mutation who have benefited from TKI. In this phase II trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for EGFR-mutant oligo-metastatic NSCLC (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of TKI therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Local radiotherapy on all sites of disease including primary and metastatic lesions
Cancer Hospital/Institute, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGProgression free survival
Duration between the first date of TKI administration and disease progression or last follow-up
Time frame: 1 year
Overall response
Post-RT response compared with the baseline status at the first data of TKI administration
Time frame: 1 month after RT
Overall survival
Duration between the first date of TKI administration and any cause of death or last follow up
Time frame: 2 year
Time to progression of initial lesions
Duration between the first date of TKI administration and the progression of the initial lesions or last follow up
Time frame: 1 year
Time to appearance of new metastatic lesions
Duration between the first date of TKI administration and the occurrence of new lesions or last follow up
Time frame: 1 year
Treatment related toxicity
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 1 year
EORTC Quality of life
Quality of life evaluation using EORTC questionnaires
Time frame: 1 year
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