Randomized phase II trial of gemcitabine(GEM) and carboplatin (CBDCA) with or without Dexamethasone(Dex) in untreated non-small cell lung cancer (NSCLC).

Randomized phase II trial of gemcitabine(GEM) and carboplatin (CBDCA) with or without Dexamethasone(Dex) in untreated non-small cell lung cancer (NSCLC). - Randomized phase II trial of dexmethasone as premedication to GEM and CBDCA

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000547

Enrollment

Registered

2007-01-01

Start date

2006-07-01

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

Gemcitabine(GEM):1000mg/m2 Day1,8 Carboplatin(CBDCA):AUC=4.5 Day1 Gemcitabine(GEM):1000mg/m2,Day1,8 Carboplatin(CBDCA):AUC=4.5,Day1 Dexamethasone(Dex) :8mg/body/day,Day-4.-3.-2.-1.0

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathological confirmed Stage IIIB IV NSCLC without previous chemotherapy 2) Measurable lesions (RECIST) 3) Age: >=20 and <80 4) no indication for radiation therapy 5) ECOG Performance Status: 0 - 1 6) Sufficient organ functions defined as: neutrophil >1500/mm3 Platelet 1000000/mm3 Hemoglobin >9.0gr/dl AST/ALT : <2.5XULN of the instituion serum T-bilirubin level<=1.5 mg/dl serum creatinine level<=1.5 mg/dl SpO2 >=95% (room air) 7) Expected survival over 3 months 8) Provided written informed consent

Exclusion criteria

Exclusion criteria: 1)Clinically apparent interstitial pneumonia in chest X ray or CT 2)Pleural or pericardial effusion, or ascites requiring treatment 3)Treated Pericardial effusion or ascites 4)SVC syndrome 5)Brain metastasis requiring treatment 6)Patients with active concomitant cancer 7)Uncontrolled diabetes 8)Severe cardiovascular diseases a.uncontrollable hypertension b.congestive heart failure c.unstable angina, myocardial infarction or PTCA/CAGB therapy within the past six months d.uncontrollable arrythmias 9) Patients with liver cirrhosis 10) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 11) Medical history of serious allergic reactions to any drug 12)Active inflammatory diseases 13)Active or chronic infectious diseases (especially patients with positive HBs-Ag or active mycobacterial infection) 14) Regular use of steroids or immunosupressive drugs 15)Refusal to blood transfusion 16)Patient with known bleeding disorders 17) Inappropriate patients for this study judged by the physicians.

Design outcomes

Primary

Measure	Time frame
Dose reduction rate (DRR) in the second cycle	—

Secondary

Measure	Time frame
Deferment rate (DR) of the second cycle Objective Response Rate (ORR) Time to progression (TTP) Overall survival (OS) Safety (Toxicity profile) Platelet transfusion rate (PER)	—

Countries

Japan

Contacts

Public ContactTadashi Mio

Kyoto University Respiratory Medicine

mio@kuhp.kyoto-u.ac.jp075-751-3830

Outcome results

None listed

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