NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001863

Registered date:08/04/2009

A Phase II study of Gefitinib as First-Line Treatment for Elderly Patients with Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedNon-Small-Cell Lung Cancer
Date of first enrollment2009/04/01
Target sample size19
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Gefitinib treatment

Outcome(s)

Primary OutcomeResponse rate
Secondary OutcomeDisease control rate, Median survival time, 1-year survival rate, Progression-free survival time, Quality of life, Adverse events

Key inclusion & exclusion criteria

Age minimum70years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) Active infection, uncontrolled heart disease or diabetes mellitus 2) Interstitial pneumonia / pulmonary fibrosis on computed tomography scan 3) Massive pleural or pericardial effusion, or ascites 4) Superior vena cava syndrome 5) Symptomatic brain metastases 6) Severe drug allergy 7) Previous radiotherapy to the primary tumor 8) Postoperative adjuvant therapy 9) Other concurrent active malignancy 10) Pregnant or breast-feeding woman

Related Information

Contact

public contact
Name Kosuke Takahashi
Address 18 Kuriyado kake-machi, Okazaki Aichi 444-0011, Japan Japan
Telephone 0564-21-6251
E-mail
Affiliation Aichi Cancer Center Aichi Hospital Department of Respiratory Medicine
scientific contact
Name Hiroshi Saito
Address 18 Kuriyado kake-machi, Okazaki Aichi 444-0011, Japan Japan
Telephone 0564-21-6251
E-mail
Affiliation Aichi Cancer Center Aichi Hospital Department of Respiratory Medicine