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PhaseII trial of Gemcitabine(G)and Platinam-doublet plus continuous maintenance Gemcitabine in untreated stage three/four squamous non-small cell lung cancer(NSCLC)

PhaseII trial of Gemcitabine(G)and Platinam-doublet plus continuous maintenance Gemcitabine in untreated stage three/four squamous non-small cell lung cancer(NSCLC) - PhaseII trial of Gemcitabine(G)and Platinam-doublet plus continuous maintenance Gemcitabine in untreated stage three/four squamous non-small cell lung cancer(NSCLC)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011794
Enrollment
33
Registered
2013-09-18
Start date
2013-03-15
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

Four cycle of gemcitabine and platinum-doublet followed by maintenance gemcitabine in 21-days cycle until progression disease

Sponsors

Hiroshima University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed squamous non-small cell lung cancer 2) Patients who have measurable lesion 3) Stage III/VI without any indications for radiotherapy, or recurrent disease after surgery 4) Patients aged from 20 older 5)ECOG PS 0-1 6) Adequate organ function, evaluated within 14 days before enrollment (registration day is day1, and on the same day two weeks ago, is impossible) as WBC >= 4,000/mm3 Plt >= 100,000/mm3 Hb >= 9 g/dL AST/ALT <=100IU/L T.Bil <= 1.5 g/dL Ccr >=60mL/min, sCr: x 1.2 of upper limit of normal or less. SpO2 >= 60torr as room air 7) Patients are excepted to live over 3 months after administration day 8)Written informed consent from the patients

Exclusion criteria

Exclusion criteria: (1) Patient having clear infection (2) Patient having hepatitis B with the activity (3) Serious complications (stroma-related pneumonia, bleeding tendency, control are poor a heart trouble, pulmonary fibrosis) The patient whom high blood pressure or diabetes have) (4) Patient having an active overlap cancer (under nondisease period five years) (5) Metastasis to brain patient having a symptom (6) Hydrothorax to need treatment, abdominal dropsy retention patient (7) Pericardial fluid retention patient (8) Patient having an anamnesis of drug allergies (9) A pregnant woman, a nursing girl and woman with the possibility (intention) of the pregnancy (10) principal investigator cases that are deemed inappropriate

Design outcomes

Primary

MeasureTime frame
Progression Free Survival

Countries

Japan

Contacts

Public ContactKazunori Fujitaka

Hiroshima University Hospital Depatment of Respiratory Medicine

fujikazu@hiroshima-u.ac.jp082-257-5196

Outcome results

None listed

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