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Carboplatin + nab-Paclitaxel treatment for non-small lung cancer with malignant pleural effusion -phase II trial-

Carboplatin + nab-Paclitaxel treatment for non-small lung cancer with malignant pleural effusion -phase II trial- - Carboplatin + nab-Paclitaxel treatment for malignant pleural effusion

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034591
Enrollment
25
Registered
2018-10-24
Start date
2018-11-01
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 lung cancer

Interventions

CBDCA + nab-Paclitaxel

Sponsors

Fukuoka University, Facutly of Medicine, Department of Respiratory Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically proven non-small lung cancer 2) Histologically proven malignant effusion 3) Age over 20-years old 4) Performance status (ECOG) = 0-2 5) Never used of anti-cancer treatment except for either kinase treatment or immuno-check point inhibitor 6) Eligible for adjuvant or relapse after surgical treatment 7) Surgical treatment after 6 weeks 8) Adjuvant treatment after one-year 9) Adequate organ functions 10) Patients who have estimated life expectancy longer than 12 weeks 11) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Allergy for either nab-Paclitaxel or Paclitaxel 2) Severe complications such as intersitial pneumonia, CHF, CRF, liver damage, uncontrolled DM or HT 3) Symptomatic brain metastasis 4) Need for dainage 5) History of pleurodesis 6) Surgical treatment within 2 weeks 7) Active infection 8) Active multiple malignancy 9) Uncontrolled mental sympotoms 10) Pregnancy or pregnant possibiltiy 11) Administration of corticosteroids 12) Patients whom doctor consider ineligible

Design outcomes

Primary

MeasureTime frame
Control rate for malignant pleural effusion

Secondary

MeasureTime frame
RR, PFS, OS Safety, one-year survival rate Time for increase of pleural effusion Rate of patients who did not require pleurodesis

Countries

Japan

Contacts

Public ContactFumiyasu Igata

Fukuoka University, Facutly of Medicine Department of Respiratory Medicine

figata@fukuoka-u.ac.jp0928011011

Outcome results

None listed

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