A phase II randomized trial in completely resected Non-Small-Cell Lung Cancer comparing paclitaxel / carboplatin with docetaxel / cisplatin TORG0503

A phase II randomized trial in completely resected Non-Small-Cell Lung Cancer comparing paclitaxel / carboplatin with docetaxel / cisplatin TORG0503 - A phase II randomized trial in completely resected Non-Small-Cell Lung Cancer comparing paclitaxel / carboplatin with docetaxel / cisplatin TORG0503

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001244

Enrollment

110

Registered

2008-07-11

Start date

2006-04-01

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

A:paclitaxel 200mg/m2 + carboplatin AUC6, day1 q3-4w, 3 courses B: docetaxel 60mg/m2 + cisplatin 80mg/m2, day1 q3-4w, 3 courses

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) histologically or cytologically confirmed Non-Small-Cell Lung Cancer 2) completely resected 3) pathological stage IB,IIA,IIB,IIIA(pN0-N2) 4) no prior chemotherapy or radiotherapy 5) performance status of 0-1 6) age 20-70 years old 7) adequate organ function .WBC >= 4,000 /mm3 .Neutrophil count >= 2,000/mm3 .Platelet count >= 100,000/mm3 .Hemoglobin >= 10g/dL .AST/ALT within 2.5 times the upper limit of normal (ULN) of institution .Total serum bilirubin <= 1.5 mg/dL .Serum creatinine <= 1.5 mg/dL .Creatinine crearance >=60 ml/min/body .PaO2 >= 70 torr 8) possible to receive chemotherapy within 4-10 weeks after surgery 9) written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
2-year relapse free survival	—

Secondary

Measure	Time frame
Overal survival Incidence of an adverse event QOL(FACT-T) Feasibility	—

Countries

Japan

Contacts

Public ContactKaoru Kubota

National cancer center east Thoracic Oncology Division

04-7133-1111

Outcome results

None listed

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