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A phase II study of CBDCA and TS-1 in patients with advanced non-small cell lung cancer

A phase II study of CBDCA and TS-1 in patients with advanced non-small cell lung cancer - A phase II study of CBDCA and TS-1

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001746
Enrollment
35
Registered
2009-03-03
Start date
2007-06-01
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

Advanced non-small cell lung cancer

Interventions

Sponsors

Gunma University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven non-small cell lung cancer 2)Stage IIIB with no induction of radiation therapy, and Stage IV 3)Age range from 20 to 74 years 4)ECOG performance status of 0 or 1 5)a life expectancy of 12 weeks or more 6)Measurable by RECST criteria 7)no previous chemotherapy or radiotherapy 8)adequate bone marrow, liver, and renal functions WBC > 4000 mm-3 Neutro > 2000 mm-3 Platlets > 100000 mm-3 Hb > 9 g dL-1 T-Bil< 1.5 mg dL-1 AST, ALT<100IU/L s-Cr < 1.5 mg dL-1 CCr > 60 mL min-1 PaO2>70torr 9)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Pulmonary fibrosis detectable on chest X-ray films 2)Massive pleural effusion, ascites and pericardial effusion required drainage 3)Concomitant malignancy 4)Serious medical complications: uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. Uncontrolled diabetes mellitus, hypertension, infection (ileus, bleeding, superior vena cava syndrome 5)Symptomatic brain metastasis 6)Pregnant or milk-feeding female. Intention to be pregnant in the future 7)With severe allergy 8)Other clinical difficulties to this study

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
To assess toxicity, overall survival and progression-free survival

Countries

Japan

Contacts

Public ContactNoriaki Sunaga

Gunma University Hospital Department of Respiratory Medicine

nsunaga@showa.gunma-u.ac.jp027-220-7111

Outcome results

None listed

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