Adjuvant cisplatin and vinorelbine in patients with completely resected pathological II-IIIA non-small cell lung cancer.

Adjuvant cisplatin and vinorelbine in patients with completely resected pathological II-IIIA non-small cell lung cancer. - Adjuvant CDDP + VNR for pII-III NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005055

Enrollment

Registered

2011-02-09

Start date

2006-12-01

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

adjuvant chemotherapy, consisting of cisplatin and vinorelbine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Disease: patients with completely resected non-small cell lung cancer Opetation mode: lobectomy, bilobectomy, or pneumonectomy with regional and mediastinal lymphnode disection. Pathological stage: IIA, IIB, IIIA in UICC criteria ECOG Performance status: 0 - 1. No other active malignancies Laboratory data: WBC >= 4000 /mm3, Neutrophil >= 2000 /mm3, Hemoglobin >= 10 g/dl, Platelet >= 100,000 /mm3 GOT and GPT =< 2.5UNL T-bil =< 1.5 mg/dl s-Cre =< 1.5 mg/dl PaO2 >= 65 mmHg or SpO2 >= 93% Written informed consent

Exclusion criteria

Exclusion criteria: Patients receiving induction chemotherapy, radiotherapy for corresponding NSCLC Patients receiving other postoperative chemotherapy / radiotherapy (Pleurodesis with OK-432 is excluded.) Patients with other active malignancy. Patients with active infection. Patients with cardiac diseases which are not well-controlled. Patients with interstitial lung diseases. Patients with uncontrolled diabetes mellitus Patients with a disease which needs steroid treatment Patients who have allergy to CDDP or VNR Patients in pregnancy or during lactation

Design outcomes

Primary

Measure	Time frame
Recurrence-free survival	—

Secondary

Measure	Time frame
Overall survival, adverse effects	—

Countries

Japan

Contacts

Public ContactMakoto Sonobe

Kyoto University Hospital Department of Thoracic Surgery

mysonobe@kuhp.kyoto-u.ac.jp075-751-4975

Outcome results

None listed

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