A pilot phaseII study of 3 dimensional stereotactic radiotherapy (3D-SRT) followed by maintenance therapy with oral UFT for stage IB non - small cell lung cancer

A pilot phaseII study of 3 dimensional stereotactic radiotherapy (3D-SRT) followed by maintenance therapy with oral UFT for stage IB non - small cell lung cancer - Pilot study of 3 dimensional stereotactic radiotherapy and oral UFT for stage IB NSCLC.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000180

Enrollment

Registered

2005-09-12

Start date

2004-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non - small cell lung cancer, stageIB.

Interventions

Oral UFT 250mg/m2 therapy for two years from the 57th day after 3 dimensional stereotactic radiotherapy (3D-SRT) which consists of consecutive 4 days of 12 Gray irradiation per fraction per day (total

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed non-small cell lung cancer 2)Stage IB 3)No previous pulmonary irradiation 4)ECOG PS 0-2 5)Measurable lesions(10g/dL, 3000/mm31,500/mm3, Platelet count> 12000/mm3, GOT and GPTTorr (room air), FEV1.0>700ml, %VC>50%, ejection fraction>60% 9)Life expectancy for more than 6 months 10)An inoperable patient or patient who refuses operation 11)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Apparent interstitial pneumonitis or fibrosis on chest X ray 2)Irradiation field larger than half of a ipsilateral lung 3)Double cancer within 5 years except for carcinoma in situ, intramucosal tumor, and basal cell carcinoma of the skin 4)History of previous chemotherapy 5)Pregnant woman, lactating woman, woman who has a possibility of pregnancy 6)Uncontrolled angina pectoris, myocardial infarction and congestive heart failure within three months 7)Uncontrolled diabetes mellitus 8)Active infectious disease 9)Fever more than 38 degrees Celsius 10)Steroid administration 11)Other complication unsuitable for the study

Design outcomes

Primary

Measure	Time frame
3-year survival	—

Secondary

Measure	Time frame
Progression free survival, median survival time, local progression free survival time, local progression free survival at 3 years, pattern of progression or recurrence, adverse events, 5-year survival rate, local progression free survival at 5 years	—

Countries

Japan

Contacts

Public ContactReiko Naya

Institute of Biomedical Research and Innovation Department of Translational Research Division of Integrated Oncology

naya@kcgh.gr.jp078-304-5200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026