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| Name | Class |
|---|---|
| Pamela Youde Nethersole Eastern Hospital | OTHER |
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To determine the efficacy of preemptive local ablative therapy in NSCLC patients with activating EGFR mutation who have oligometastatic residual metabolic-active disease after first-line EGFR TKI, as measured by PFS rate at 1 year from the trial enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preemptive local ablative therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preemptive local ablative therapy | Radiation |
| ||
| Oral TKI |
| Measure | Description | Time Frame |
|---|---|---|
| PFS rate at 1 year | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 2 years | |
| Progression-free survival | 2 years | |
| radiologic change on PET-CT scan 3 months after SABR |
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Inclusion Criteria:
Pathologically confirmed UICC 7th edition Stage IIIB (not amenable for curative intent local radiotherapy)/IV (metastatic or recurrent) non-small cell carcinoma of lung
Documented activating EGFR mutation (exon 19 deletion or exon 21 L858R only) in tumor tissues
Treated with first-line EGFR TKI for 3 months and achieved good radiological partial response that was documented with a CT scan
Not more than 4 residual metabolic active (SUVmax > 2.5) metastatic sites left on the screening PET-CT scan. (one bone metastatic site is regarded as a single site, mediastinal/ hilar lymph nodes in close proximity and possible to be treated in an acceptable volume is regarded as one lesion)
The shortest diameter of the lesion must be ≥ 1cm and is amenable to local ablative therapy
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
Age ≥ 18 years
Pleural or pericardial effusion at diagnosis is allowed only if it has resolved on CT scan after 3-month EGFR TKI treatment
Brain metastasis at diagnosis is allowed if it has been treated either surgically or with radiotherapy and there is no radiological progression on follow-up CT scan. The patient is neurologically stable for at least 1 week after cessation of steroid treatment
Adequate organ function as defined by the following criteria:
Written informed consent that is consistent with ICH-GCP guidelines
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kwok Chi LAM, FRCP | Prince of Wales Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Oncology | Hong Kong | Hong Kong |
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RT + Oral TKI
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| Drug |
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| 3 months |
| Number of Participants with Adverse Events as a Measure of safety | 2 years |