Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer

Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer - Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001032

Enrollment

Registered

2008-04-01

Start date

2008-02-01

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, S-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients must have histologically or cytologically confirmed non-small cell lung cancer that is inoperable or unsuitable for radical radiotherapy Stage IIIB or Stage IV. Recurrence after surgery is allowed. 2) Patient has measurable disease. 3) Patient has no prior chemotherapy. Patients who had received previous radiotherapy are included if their assessable disease is outside of the radiation field. 4) Patients must be greater than or equal to 75 years of age. 5) ECOG performance status 0 or 1 6) Laboratory values must be as follows; WBC count greater than or equal to 4,000/mm3,absolute neutrophil count greater than or equal to 2,000/mm3, platelet count greater than or equal to 100,000/mm3, hemoglobin greater than or equal to 9.0g/dL, AST and ALT within twice the upper limit of normal for the institution,bilirubine level less than or equal to 1.5 mg/dL, serum creatinine within the upper limit of normal, or creatinine clearance greater than or equal to 60 mL/min, PaO2 greater than or equal to 60 torr 7) Estimated life expectancy 3 months 8) Patients must sign an informed consent.

Exclusion criteria

Exclusion criteria: 1)No interstitial pneumonia or pulmonary fibrosis, as determined by chest x-ray 2)A history of severe allergic reactions to drugs 3) Patients with concurrent serious infections or complications are excluded 4) Clinically significant pleural/pericardial effusion which requires drainage before study entry. 5) Patients with an unstable or serious heart disease 6) Inadequately controlled diabetes mellitus 7) Symptomatic brain metastases 8) The presence of other concomitant or metachronous cancers 9)Any concomitant pathology that would, in the investigator`s opinion, contraindicate the use of the drugs in the protocol

Design outcomes

Primary

Measure	Time frame
progression-free survival	—

Secondary

Measure	Time frame
compliance, safety, response rate, overall survival time	—

Countries

Japan

Contacts

Public ContactShinji Atagi

National Hospital Organization Kinki-chuo Chest Medical Center Internal Medicine

0722-52-3021

Outcome results

None listed

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