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The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer

The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer - The Phase II Study of Docetaxel plus Nedaplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004634
Enrollment
30
Registered
2010-11-30
Start date
2010-12-01
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) (day 1) + Nedaplatin (80mg/m2) (day 1) q4weeks, 4 cycles

Sponsors

Shiga University of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically determined non-small cell lung cancer 2. Completely resected 3. Pathological stage IB, IIA, IIB, IIIA 4. Neither previous chemotherapy nor radiotherapy as adjuvant therapy 5. Aged 20-79 years old 6. ECOG performance status 0 or 1 7. Adequate organ function 8. Possible to receive chemotherapy within 4-8 months after surgery 9. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Allergy against polysorbert 80 or platinum-containing drugs 2. Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, hemorrhagic tendency) 3. Active infections 4. Massive pleural or pericardial effusion 5. Active simultaneous cancer 6. Active interstitial pneumonitis or its past history 6. Peripheral nerve disorders 7. Pregnant or lactating women 8. Other conditions not suitable for this study

Design outcomes

Primary

MeasureTime frame
Feasibility

Secondary

MeasureTime frame
Disease-free survival Overall survival Safety

Countries

Japan

Contacts

Public ContactKoji Teramoto

Shiga University of Medical Science Department of Surgery

077-548-2244

Outcome results

None listed

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