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Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer

Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer - Phase I/II Trial of S-1 plus paclitaxel combination chemotherapy in elderly patients with non-small lung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003782
Enrollment
45
Registered
2010-06-18
Start date
2010-06-01
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

S-1 plus Paclitaxel

Sponsors

Kyoto prefectural University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with NSCLC confirmed pathologically 2)Patients who have at least one or more measurable lesion 3)Unresectable stage IIIB or IV NSCLC 4)No previous chemotherapy or radiotherapy 5)An age more than 70 years or equal 6)Performance status (ECOG) :0-1 7)Adequate organ functions 8)A life expectancy of 2 months or more 9)With ability of oral intake 10)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with serious complication 2)Patients with active double cancer 3)Patients with previous serious drug hyperseneitivity 4)receiving Flucytosine 5)Patients with alcohol allergy 6)Other conditions inadequate for this research

Design outcomes

Primary

MeasureTime frame
Phase I maximum tolerated dose, recommended dose Phase II response rate

Secondary

MeasureTime frame
Phase I toxicity, response rate Phase II toxicity, disease control rate, overall survival, relation to biomarker

Countries

Japan

Contacts

Public ContactYoshinobu Iwasaki

Kyoto prefectural University of Medicine Department of Respiratory Medicine

yiwasaki@koto.kpu-m.ac.jp075-251-5513

Outcome results

None listed

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