To explore the survival benefit of the gefitinib combined with radiotherapy as adjuvant therapy for completely resected patients with Pathological stage IIIA-N2 NSCLC harbouring sensitive mutations of EGFR.
Name: GefitinibDescription: Gefitinib 250 mg/day oral dailyType: Drug
Gefitinib + Radiotherapy
Description: From start of anti-cancer therapy until progression or death. To evaluate the disease free survival of gefitinib combined with radiotherapy as adjuvant therapy in completely resected patients with Pathological stage IIIA-pN2 NSCLC harbouring sensitive mutations of EGFR.Disease free survival (DFS)- defined as the time from initial medication to the first documented disease progression or death, whichever occurs first.Measure: Disease free survival Time: CT scan, abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan every 12 months for up to 3 years.
Description: evaluated in the 6 years since treatment begainMeasure: Overall survival Time: 6 years
Description: To compare the adjuvant treatment arm in terms of 3 yeas DFS rate.Measure: 3 yeas DFS rate Time: 3 years
Description: To compare the adjuvant treatment arm in terms of 5 years DFS rate.Measure: 5 years DFS rate Time: 5 years
Description: To compare the adjuvant treatment arm in terms of 5 years OS rate.Measure: 5 years OS rate Time: 5 years
Description: The safety and tolerability profile of gefitinib at a 250 mg daily dose relative to that of radiotherapy.Measure: Number of Participants with Adverse Events Time: In the period of Gefitinib 250 mg/day oral daily for 24 months. Radiotherapy total dose 50-54Gy, divided dose 1.8-2Gy.
Single Group Assignment
There are 2 SNPs
- Target population is completely resected pathological stage IIIA-N2 NSCLC with EGFR exon 19 deletions and exon 21 L858R activating mutation. --- L858R ---
- Patients who harbouring exon 20 T790M mutation. --- T790M ---