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 mutation

JRCT ID: jRCTs071180036

Registered date:11/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 14/04/2011
• Target sample size: 21
• Study type: Interventional
• Intervention(s): Gefitinib followed by cisplatin and docetaxel with concurrent radiotherapy

Outcome(s)

• Primary Outcome: Two year survival rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1) Non small-cell lung cancer proven cytologically or histologically
2)Patients having EGFR mutation (exon 19 deletion or L858R)
3)treatment naive c-stage IIIA or IIIB
4) Patient who has measurable lesion by RECIST v1.1.
5) V20 in radiation field <= 35%
6) oral intake possible
7) Performance status (ECOG) 0-2.
8) age 20-74 years old
9)adequate organ functions (within 2 weeks before registration)
1.WBC >= 3,500/mm3
2.Neu >= 2,000/ mm3
3.Plt >= 100,000/ mm3
4.Hb >= 9.0g/dl
5.AST and ALT, x 2 of upper limit of normal (ULN) or less
6.T-Bil < 1.5mg/dl
7.Serum creatinin, x 1.5 of ULN or less
creatinine clearance>=60ml/min
8. SpO2 or blood gas SpO2 >= 90% or PaO2 >= 60 torr
9) Lung function Forced expiratory volume in 1 second More than 1.5L
10)Written informed consent

Exclude 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 disease
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

Related Information

• Primary Sponsor: Hotta Katsuyuki
• Secondary ID(s): UMIN000005086