Feasibility study of TS-1 after surgery with Cisplatin/Docetaxel in completely resected pathological stage II/IIIA non-small cell lung cancer (TORG0809)

Feasibility study of TS-1 after surgery with Cisplatin/Docetaxel in completely resected pathological stage II/IIIA non-small cell lung cancer (TORG0809) - TS-1 after surgery with CDDP+Docetaxel for p-stage II/IIIA NSCLC(TORG0809)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001779

Enrollment

125

Registered

2009-04-01

Start date

2009-04-01

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

After CDDP 80mg/m2 + Docetaxel 60mg/m2, day 1 q3-4w, 3 courses, TS-1 80mg/m2 b.i.d., day 1-14 q3w, more than 6 months, maximum 1 year

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) pathologically proven Non-small Cell Lung Cancer 2) pathological stage II, IIIA 3) complete resection 4) at least lobectomy 5) LN dissection (ND2a) or Elective Lymph Node Dissection 6) no prior anti cancer treatment for thoracic malignancy except for this operation 7) ECOG PS 0-1 8) more than 20 years of age, under 75 years of age 9) adequate organ function 10) within 10 weeks after surgery 11) signed informed consent

Exclusion criteria

Exclusion criteria: 1) not recovered from surgical complications 2) active infection such as bacterial infection 3) patients with interstitial pneumonaitis or pulmonary fibrosis, as determined by chest CT 4) patients with myocardial infraction within 6 months 5) patinets with uncontroled complications 6) grade 2 or greater peripheral neuropathy 7) active concomitant malignancy 8) pregnant or lactating woman 9) past history of allergic reactions to polysorbate 80 10) concomitant therapy with flucytocine 11) pneumonectomy 12) other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
treatment completion proportion	—

Secondary

Measure	Time frame
overall survival, relapse free survival, pattern of recurrence, adverse events	—

Countries

Japan

Contacts

Public ContactSeiji Niho

National Cancer Center Hospital East Thoracic Oncology Division

siniho@east.ncc.go.jp04-7133-1111

Outcome results

None listed

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