NIPH Clinical Trials Search

UMIN ID: UMIN000001755

Registered date:05/03/2009

Randomized phase 3 trial of prophylactic cranial irradiation for patients with extensive small-cell lung cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedExtensive small-cell lung cancer patients with no brain metastasis who had a response to platinum-based first-line chemotherapy,
Date of first enrollment2009/03/01
Target sample size330
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Prophylactic cranial irradiation 25Gy (2.5 Gy X 10frs) No therapy


Primary OutcomeOverall survival
Secondary OutcomeIncidence of brain metastasis, Time to brain metastasis, Progression free survival, Adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1. Previous radiotherapy to the head and neck area overlapped with PCI field. 2. Another active cancer 3. Serious psychological and/or physiological complications 4. An expectant or lactating woman

Related Information


public contact
Name Toshiaki Takahashi
Address 1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, 411-8777 Japan
Telephone 055-989-5222
Affiliation Shizuoka Cancer Center Division of Thoracic Oncology
scientific contact
Name Nobuyuki Yamamoto
Address 811-1, Kimiidera,Wakayama City,Wakayama, 641-8509, Japan Japan
Telephone 073-441-0619
Affiliation Wakayama Medical University Third department of Internal Medicine