A phase II trial of postoperative adjuvant chemotherapy with carboplatin/ docetaxel for the patients completely resected Non Small Cell Lung Cancer

A phase II trial of postoperative adjuvant chemotherapy with carboplatin/ docetaxel for the patients completely resected Non Small Cell Lung Cancer - A phase II trial with carboplatin/ docetaxel in completely resected Non Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002425

Enrollment

Registered

2009-09-01

Start date

2009-09-01

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

docetaxel 60mg/m2, day1 + carboplatin AUC 5mg/mLxmin, day 1 q3w, 3 cycles

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) pathologically proven non-small cell lung cancer and possible to receive chemotherapy within 4-10 weeks after surgery 2) completely resected NSCLC and pathological stage IB, II, IIIA 3) no prior chemotherapy or radiotherapy 4) PS 0 or 1 5) age 20-80 6) written informed consent 7) adequate organ function .WBC>=4000/mm3<=12000/mm3 .neutrophil<=2000/mm3 .platelet<=100000/mm3 .AST,ALT within 2 times of upper limit .total bilirubin <=1.5 mg/dl .creatinin<= 1.2 mg/dl .creatinin clearance>=60ml/min/body PaO2>=60Torr

Exclusion criteria

Exclusion criteria: 1) active infection 2) fever 3) severe complication 4) concomittant malignant cancer 5) Uncontroled pleural effusion or ascitis 6) Pericardial effusion 7) Neuropathy 8) past history of severe allergic reaction 9) Pregnant or expecting woman 10) other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
feasibility	—

Secondary

Measure	Time frame
safety, progression-free survival	—

Countries

Japan

Contacts

Public ContactHidetaka Uramoto

UOEH Second Department of Surgery

hidetaka@med.uoeh-u.ac.jp093-691-7442

Outcome results

None listed

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