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.
Cisplatin-based adjuvant chemotherapy is standard of care for patients with stage II-IIIA non-small cell lung cancer (NSCLC). Activating somatic mutations of the tyrosine kinase domain of epidermal growth factor receptor (EGFR) have been characterized in a subset of patients with advanced NSCLC. The recently study of gefitinib (G) versus vinorelbine+cisplatin (VP) as adjuvant treatment in stage II-IIIA (N1-N2) NSCLC with EGFR-activating mutation (ADJUVANT)shows that G had significantly longer median DFS (28.7 months) than VP (18.0months). 3-year DFS was significantly better with G (34.0% vs 27.0%; p= 0.013) and subgroup analysis of patients treated with G, lymph node status (pN1/N2) demonstrated significant correlation with DFS. At present, postoperative radiotherapy has been widely used in the treatment of all kinds of cancer, and the guidelines also recommend postoperative radiotherapy for stage IIIA-pN2 NSCLC. The retrospective study of Lee et. al. reported on the use of postoperative radiotherapy (PORT) as first strategy after resection of stage IIIA-pN2 NSCLC. The result showed that the five-year overall OS was significantly higher in patients treated with PORT and postoperative chemotherapy (POCT) than in patients treated with PORT alone. This open-label phase II trial is studying gefitinib combined with radiotherapy to see how well it works in treating patients who have undergone surgery for Pathological stage IIIA-N2 NSCLC with EGFR activating mutation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Gefitinib 250 mg/day oral daily
China-Japan Friendship Hospital
Beijing, China
Disease free survival
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.
Time frame: CT scan, abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan every 12 months for up to 3 years.
Overall survival
evaluated in the 6 years since treatment begain
Time frame: 6 years
3 yeas DFS rate
To compare the adjuvant treatment arm in terms of 3 yeas DFS rate.
Time frame: 3 years
5 years DFS rate
To compare the adjuvant treatment arm in terms of 5 years DFS rate.
Time frame: 5 years
5 years OS rate
To compare the adjuvant treatment arm in terms of 5 years OS rate.
Time frame: 5 years
Number of Participants with Adverse Events
The safety and tolerability profile of gefitinib at a 250 mg daily dose relative to that of radiotherapy.
Time frame: In the period of Gefitinib 250 mg/day oral daily for 24 months. Radiotherapy total dose 50-54Gy, divided dose 1.8-2Gy.
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