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Feasibility Study of Adjuvant Chemotherapy with UFT Following Stereotactic Body Radiation Therapy for Clinical Stage I Non-Small Cell Lung Cancer (LOGIK-1001)

Feasibility Study of Adjuvant Chemotherapy with UFT Following Stereotactic Body Radiation Therapy for Clinical Stage I Non-Small Cell Lung Cancer (LOGIK-1001) - Feasibility Study of UFT following Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer. (LOGIK-1001)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004789
Enrollment
45
Registered
2010-12-24
Start date
2010-05-01
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

Clinical Stage I Non-small Cell Lung Cancer Treated with Stereotactic Body Radiation Therapy

Interventions

UFT250 mg/m2(daily oral administration)for 2years

Sponsors

Lung Oncology Group in Kyushu, Japan (LOGIK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically or transbronchoscopic cytologically or Clinically(exe. FDG-PET) confirmed non-small cell lung cancer 2.StageIB(T1-2a, N0, M0) with images 3.Undergone curative stereotactic body radiation therapy 4.No prior therapy other than stereotactic body radiation therapy 5.Aged 20<= years. 6.ECOG performance status of 0-1. 7.Required baseline laboratory parameters (within 2 weeks before registration): WBC >= 3000/mm3 Neu >= 1,500/ mm3 Hb >= 10g/dl Plt >= 100,000/ mm3 GOT < 100IU/ml GPT < 100IU/ml T-Bil <= 2.0mg/dl Cre <= 1.5mg/dl PaO2 >= 60Torr 8.Written informed consent.

Exclusion criteria

Exclusion criteria: 1.Apparent interstitial pneumonitis and fibrosis 2.Active inflammation without oral drugs 3.Double cancer 4.Pregnancy 5.Psychiatric disorder 6.Steroid administration 7.Oxygen administration 8.Fever of 38.0 degrees centigrade or higher

Design outcomes

Primary

MeasureTime frame
Completion Rate of UFT therapy

Secondary

MeasureTime frame
Adverse events, Grade 2 or greater radiation pneumonitis, Disease-free survival, Overall survival

Countries

Japan

Contacts

Public ContactYoshiyuki Shioyama

Kyushu University, Graduate School of Medical Sciences Department of Heavy Particle Therapy and Radiation Oncology

shioyama@radiol.med.kyushu-u.ac.jp092-642-5695

Outcome results

None listed

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