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A phase II randomized trial in completely resected non-small cell lung cancer comparing paclitaxel / carboplatin with TS-1

A phase II randomized trial in completely resected non-small cell lung cancer comparing paclitaxel / carboplatin with TS-1 - A phase II randomized trial in completely resected non-small cell lung cancer (PTX/CBDCA vs TS-1)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001510
Enrollment
100
Registered
2008-11-18
Start date
2008-11-01
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

A: paclitaxel 120mg/m2 + carboplatin AUC 3, day1 and day15, q4w, 4 course B: TS-1 80mg/m2 oral, day1 to 14, q3w, 1 year

Sponsors

Nagoya City University thoracic oncology study group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) pathologically proven non-small cell lung cancer 2) completely resected by lobectomy or pneumonectomy (+ other resection) 3) pathological stage II or IIIA (IASCL ver.7) 4) no prior chemotherapy or radiotherapy 5) PS 0 or 1 6) age 20-75 7) adequate organ function .WBC>=3500/mm3<=12000/mm3 .neutrophil<=2000/mm3 .platelet<=100000/mm3 .AST,ALT within 2 times of upper limit .total bilirubin within 2 times of upper limit .SpO2>=95% .creatinin within upper limit .creatinin clearance>=60ml/min/body 8) possible to receive chemotherapy within 8 weeks after surgery 9) oral intake possible 10) written informed consent

Exclusion criteria

Exclusion criteria: 1) apparent interstitial pneumonitis or pulmonary fibrosis 2) uncontroled pleural effusion or ascitis 3) multiple lung cancer 4) concomittant malignanct 5) past history of radiotherapy or chemotherapy 6) active infection or uncontroled complication 7) past history of severe allergic reaction 8) Pregnant or expecting woman 9) other conditions not suitable for this study

Design outcomes

Primary

MeasureTime frame
2-year relapse free survival

Countries

Japan

Contacts

Public ContactMotoki Yano

Nagoya City University Graduate school of Medical Sciences Department of Oncology, Immunology, and Surgery

Outcome results

None listed

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