Phase II trial of induction gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer with EGFR activating mutatio
Phase 2
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000005086
- Lead Sponsor
- ung Oncology Group in Kyushu, Japan (LOGIK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients having EGFR gene mutation (T790M) 2) Past history of drug hypersensitivity 3) Patients with superior vena cava (SVC) syndrome 4) pulmonary fibrosis or interstitial pneumonitis evident on chest CT 5) serious heart dosease 6) Psychiatric disorder 7) uncontrollable diabetes 8) paresis of intestine, intestinal obstruction 9) Patients with active severe infections 10) serious complications other 11) Patients with active concomitant malignancy 12) Pregnant or lactation women, or women with known or suspected pregnancy 13) Inappropriate to entry by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two year survival rate
- Secondary Outcome Measures
Name Time Method Survival time, progression free survival time, five year survival rate, completion rate of protocol therapy, response rate of induction therapy, response rate of chemoradiation, site and type of progression, incidence of adverse events, correlation between radiation field and survival, correlation between protein expression of molecular marker; ERCC1, RRM1, BRCA1, TSP1, TXR1, thioredoxin, and efficacy or safety