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Randomized scheduling feasibility study of S-1 for adjuvant chemotherapy in patients with completely resected non-small cell lung cancer

Randomized scheduling feasibility study of S-1 for adjuvant chemotherapy in patients with completely resected non-small cell lung cancer - S-1 for adjuvant chemotherapy in NSCLC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016086
Enrollment
80
Registered
2014-12-30
Start date
2005-04-01
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

Interventions

Arm A receiving oral S-1 of 4-week administration followed by 2-week rest for 12 months Arm B receiving oral S-1 of 2-week administration followed by 1-week rest for 12 months

Sponsors

Division of Chest Surgery, Toho University Omori Medical Center
Lead Sponsor
Division of Surgery, Toho University Ohashi Medical Center Division of Surgery, Toho University Sakura Medical Center Department of Thoracic Surgery, National Defense Medical College Hospital Department of Thoracic and Cardiovascular Surgery, Self-Defense Forces Central Hospital Division of Respiratory Medicine, Toranomon Hospital Respiratory Diseases Center, International University of Health and Welfare, Mita Hospital Department of Thoracic Surgery, Mitsui Memorial Hospital Division of
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Completely resected non-small cell lung cancer 2) Adenocarcinma, large cell carcinoma, squamous cell carcinoma, or adeno-squamous cell carcinoma 3) Stage IB-IIIA 4) Age 20-75 year-old 5) ECOG Perfomance Status 0-1 6) Adequate organ function 7) Able to start within 9 weeks after the surgery 8) No prior therapy 9) Written informed concent

Exclusion criteria

Exclusion criteria: 1) Interstitial pneumonia 2) Pleural effusion, ascites, cardiac effusion 3) Active double malignancies 4) Serious medical complications 5) Diarrhea 6) Pregnancy, breastfeeding or suspected of being pregnant 7) Male with intent of reproduction 8) Drug allergy 9) Allergy to ingredients of S-1 10) Administering fluorinated pyrimidine other than S-1 11) Administering flucytosine 12) Others judged by attending physician

Design outcomes

Primary

MeasureTime frame
Cumulative rate of total administration days of S-1, relative dose intensity, and adverse events—

Secondary

MeasureTime frame
Three-year-relapse free survival—

Countries

Japan

Contacts

Public ContactYoshinobu Hata

Toho University Omori Medical Center Division of Chest Surgery

hata@med.toho-u.ac.jp03-3752-4151

Outcome results

None listed

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