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Docetaxel,Cisplatin versus Carboplatin,weekly Paclitaxel for patients with advanced non-small cell lung cancer : a prospective randomized phase II study of the Niigata Lung Cancer Treatment Group

Docetaxel,Cisplatin versus Carboplatin,weekly Paclitaxel for patients with advanced non-small cell lung cancer : a prospective randomized phase II study of the Niigata Lung Cancer Treatment Group - Docetaxel,Cisplatin versus Carboplatin,weekly Paclitaxel for patients with advanced non-small cell lung cancer : a prospective randomized phase II study of the Niigata Lung Cancer Treatment Group

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001132
Enrollment
80
Registered
2008-04-28
Start date
2004-08-01
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

Treatment group A: DOC 45mg/m2 day1,15 CDDP 40mg/m2 day1,15 Treatment group B: PTX 70mg/m2 day1,8,15 CBDCA AUC = 6 day1

Sponsors

Niigata Lung Cancer Treatment Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients enrolled in this trial had histologically or cytologically confirmed NSCLC who are in-operable or not candidates for thoracic radiation, if they had not received previous chemotherapy, had measurable disease, and had a life expectancy of at least 3 months. Additional entry criteria were age 20=< years, performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, and adequate bone marrow (leukocyte count > 4,000/mm3, <12,000/mm3, neutrophil count>2,000/mm3, hemoglobin concentration > 9.5g/dL, platelet count > 100,000/mm3), kidney (creatinine < 1.2 mg/dL), liver (aspartate aminotransferase[AST] and alanine aminotransferase [ALT] < 100, total bilirubin < 2.0 mg/dL), and pulmonary (PaO2 > 60 torr) functions.

Exclusion criteria

Exclusion criteria: Patients were excluded if they had any active concomitant malignancies,infections, symptomatic brain metastases, past history of severe allergic reactions to drugs, interstitial pneumonia identified by chest X-ray, superior vena cava syndrome, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction within 6 months,uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites.

Design outcomes

Primary

MeasureTime frame
Response rate, survival

Secondary

MeasureTime frame
Progression free survival,safety, toxicity, QOL

Countries

Japan

Contacts

Public ContactHirohisa Yoshizawa

Niigata University Medical and Dental Hospital Bioscience Medical Research Center

hy0522@med.niigata-u.ac.jp025-227-2517

Outcome results

None listed

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