Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer

Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer - Phase I/II study of first line chemotherapy with TS-1 in elderly patients with advanced non-small cell lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002994

Enrollment

Registered

2010-01-07

Start date

2005-11-01

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

TS-1:65mg/m2/day-80mg/m2/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically Proven non-small cell lung cancer 2)Stage IIIB with no induction radiation therapy,or Stage IV 3)Age range older than 75 4)No previous chemotherapy surgery or radiotherapy 5)Measurable by RECIST criteria 6)Adequate bone narrow,liver, and renal functions Hb:over9.0g/dl WBC:4000-12000mm3 Neutro:over2000mm3 PLT:over100000/mm3 T-Bil:underNUMx1.5 AST,ALT:under100IU Ccr:over30ml/min PaO2:over60mmHg 7)ECOG Performance status of 0-2 8)Life expectancy of 12 weeks or more 9)Nomal EKG 10)Written informed concent

Exclusion criteria

Exclusion criteria: 1)Serious medical complications 2)Patients with active lung disease such as interstitial pneumonia, pulmonary fibrosis 3)Massive pleural effusion,ascites and penicardial effusion requires drainage 4)Symptomatic brain metastasis 5)History of severe allergy 6)Received radiotherapy to primary region 7)Concomitant malignancy 8)Other clinical difficulties to this study

Design outcomes

Primary

Measure	Time frame
Response rate	—

Countries

Japan

Outcome results

None listed

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