A phase II study of gefitinib with TRT in patients with stage III NSCLC harboring EGFR mutations (A phase II study of gefitinib with TRT in patients with stage III NSCLC harboring EGFR mutations)

Completed

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: jRCTs041180080

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-24
• Study First Submitted: 2019-03-11
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1. Pathologically confirmed NSCLC
2. Treatment naive unresectable stage III disease
3. Harboring EGFR mutation
4. Age of 20 to 75 years
5. ECOG PS of 0 or 1
6. Evaluable target lesions as per RECIST ver. 1.1
7. Adequate organ function
8. Confirmed as eligible for the protocol defined radiotherapy by radiologists
9. Written informed consent

Exclusion Criteria

1. Harboring exon 20 T790M mutation.
2. Incapable of oral intake
3. With intestinal paralysis, or ileus
4. Chronic diarrhea 5)Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT
5. Active infection
6. Positive for HBs antigen
7. Uncontrolled diabetes mellitus
8. Severe heart disease
9. Systemic treatment with steroids
10. Concomitant cancers within 5 years
11. Prior history of thoracic radiotherapy
12. History of sereous drug allegies
13. Pregnancy, breast feeding, or hesitation in contraception
14. Other conditions not suitable for this study

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		Progression free survival rate at 2 years.