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A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.

A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer. - A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000135
Enrollment
40
Registered
2005-09-08
Start date
2005-03-01
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

The treatment schedule included carboplatin AUC 4 on day 1, and gemcitabine 1000 mg/ m2 on days 1 and 8, every 3 weeks. (Below six courses more than three courses.)

Sponsors

Institute of Biomedical Research and Innovation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with histologic or cytologic confirmation of locally advanced or metastatic NSCLC 2)Received either no prior chemotherapy were eligible 3)Measurable lesions 4)Age ≥ 70; 5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 6)Adequate organ function 7)Life expectancy for more than 3 months 8)Written informed consent

Exclusion criteria

Exclusion criteria: 1)After thoracic irradiation 2)A case having severe infection and a serious complication 3)Requiring treatment pleural/ascites /pericardial effusion, 4)Interstitial pneumonia or active lung fibrosis on chest X-ray, 5)Symptomatic brain metastases 6)Double cancer 7)Others

Design outcomes

Primary

MeasureTime frame
Response Rate(according to RECIST criteria)

Secondary

MeasureTime frame
Median survival time, 1-year survival, Adverse events, Time to Progression, Quality of Life

Countries

Japan

Contacts

Public ContactTakashi Nishimura

Kobe City General Hospital Respiratory Medicine

t-nishi@kcgh.gr.jp078-302-4321

Outcome results

None listed

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