Status:
TERMINATED
Elderly NSCLC/D vs DP (JCOG0207)
Lead Sponsor:
Japan Clinical Oncology Group
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.
Detailed Description
The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large random...
Eligibility Criteria
Inclusion
- histologically or cytologically proven non-small-cell lung cancer
- stage IV, or stage III disease ineligible for definitive radiotherapy
- 70 years or older
- ECOG PS 0-1
- Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
- No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms
- No prior surgery within 4 weeks before enrollment
- No prior radiotherapy for primary tumor
- No prior radiotherapy for metastatic lesions within 2 weeks before enrollment
- Adequate organ function
- Signed informed consent
Exclusion
- Symptomatic brain metastasis
- Active another neoplasms
- Severe SVC syndrome
- Massive pericardial, pleural effusion, or ascites
- Bone metastasis emergent for palliative radiotherapy or surgery
- Uncontrollable systemic hypertension
- Heart failure, Unstable angina, Myocardial infarction within 6 months
- Uncontrollable diabetes
- Active infection
- Interstitial pneumonia/ Pulmonary fibrosis
- Hypersensitivity for polysorbate 80
- Systemic administration of corticosteroids
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00190476
Start Date
April 1 2003
End Date
April 1 2007
Last Update
September 12 2016
Active Locations (29)
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1
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan, 464-8681
2
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, Japan, 444-0011
3
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
4
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007