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Feasibility study of adjuvant chemotherapy with nanoparticle albumin-bound (nab)- paclitaxel and carboplatin in patients with completely resected pathological IB non small cell lung cancer

Feasibility study of adjuvant chemotherapy with nanoparticle albumin-bound (nab)- paclitaxel and carboplatin in patients with completely resected pathological IB non small cell lung cancer - Feasibility study of adjuvant chemotherapy with nanoparticle albumin-bound (nab)- paclitaxel and carboplatin in patients with completely resected pathological IB non small cell lung cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011215
Enrollment
35
Registered
2013-07-18
Start date
2013-08-01
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

Nab-paclitaxel 100mg/m2 on day 1,8,15 Carboplatin AUC6 q3weeks , 4 cycles.

Sponsors

Department of Thoracic Surgery , Faculty of Life Science Kumamoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Pathologically confirmed diagnosis of NSCLC. 2) Non-small cell lung cancer with stage IB 3) Completely resected 4) more than lobectomy + ND2a 5) Neither previous chemotherapy nor radiotherapy before operation 6) Performance Status (ECOG) 0-2 7) Aged 20-75 years old 8)Have adequate organ function within 14 days before study entry a.Granulocyte count 1,500/mm3 or over b.Platelet count 100,000/mm3 or over c.Hb 9.0 g/dl or over d.AST(GOT) 2.5 x the Upper Limits of Normal (ULN) or under e.ALT(GPT) 2.5 x the Upper Limits of Normal (ULN) or under f.Total bilirubin 1.5 mg/dL or under g.Serum creatinine 1.5 mg/dl or under h.PaO2 60torr or over or SpO2 90% or over 9) Written informed consent to participate. 10) Possible to receive chemotherapy within 8 months after surgery

Exclusion criteria

Exclusion criteria: 1)Anamnesis of hypersensitivity to drugs 2)Massive pleural or pericardial effusion 3)With active double cancer 4)Severe complication (ileus , interstitial pneumonia , interstitial pneumonia , pulmonary fibrosis, uncontrolled diabetes , heart failure , renal failure, hepatic failure, and so on) 5) With active infections 6) With a difficult bowel movement 7) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment. 8) Pregnancy or lactating patients 9) Uncontrolled psychiatric disease 10)With poor-controlled diabetes mellitus 11) Concurrent steroid therapy 12) With HBs or HCV 13) With HIV 14) Physician judged improper to entry this trial

Design outcomes

Primary

MeasureTime frame
The completion rate of four cycles

Countries

Japan

Contacts

Public ContactKentaro Yoshimoto

Minami Kyushu National Hospital Department of Thoracic Surgery

yoshiken-2@umin.org0995-62-2121

Outcome results

None listed

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