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A feasibility study of concurrent chemotherapy using S-1 with stereotactic body radiation therapy for clinical stage I-IIA Non-small Cell Lung Cancer (LOGIK1602)

A feasibility study of concurrent chemotherapy using S-1 with stereotactic body radiation therapy for clinical stage I-IIA Non-small Cell Lung Cancer (LOGIK1602) - A feasibility study of concurrent chemotherapy using S-1 with stereotactic body radiation therapy for clinical stage I-IIA Non-small Cell Lung Cancer (LOGIK1602)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032693
Enrollment
18
Registered
2018-06-01
Start date
2018-06-11
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

Interventions

S-1 80 mg/m2 (daily oral administration) for 2 weeks with stereotactic body radiation therapy 48 Gy/ 4 fractions

Sponsors

Clinical Research Support Center Kyushu
Lead Sponsor
Lung Oncology Group in Kyushu (LOGIK)
Collaborator

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.StageI-IIA(T1-2b, N0, M0) with images 3.No prior therapy for the disease 4.Aged 20<= years 5.ECOG performance status of 0-2 6.Required baseline laboratory parameters (within 2 weeks before registration): 1)PaO2 >= 60Torr 2)FEV1.0 >= 700 ml 3)Neu >= 1,500/ mm3 4)Hb >= 10g/dl 5)Plt >= 100,000/ mm3 6)AST < 100IU/ml 7)ALT < 100IU/ml 8)T-Bil <= 2.0mg/dl 9)Cre <= 1.5mg/dl 10)Creatinine Clearance >= 60ml/min 11)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 S-1 administration & radiotherapy

Secondary

MeasureTime frame
Adverse events, Grade 2 or greater radiation pneumonitis,Overall survival rate at 2 years, Disease-free survival rate at 2 years, Local control rate at 2 years

Countries

Japan

Contacts

Public ContactTomonari Sasaki

Graduate School of Medical Sciences, Kyushu University Division of Quantum Radiation Sciences, Department of Health Sciences

tomonari@hs.med.kyushu-u.ac.jp092-642-6726

Outcome results

None listed

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