Elderly NSCLC/D vs DP (JCOG0207)

Phase 3TerminatedNCT00190476

Japan Clinical Oncology Group230 enrolled

Overview

To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.

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 randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination. Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

230

Conditions

Non-small-cell Lung Cancer

Interventions

Weekly docetaxel aloneDRUG

Weekly docetaxel + cisplatin combinationDRUG

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. histologically or cytologically proven non-small-cell lung cancer 2. stage IV, or stage III disease ineligible for definitive radiotherapy 3. 70 years or older 4. ECOG PS 0-1 5. Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy 6. No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms 7. No prior surgery within 4 weeks before enrollment 8. No prior radiotherapy for primary tumor 9. No prior radiotherapy for metastatic lesions within 2 weeks before enrollment 10. Adequate organ function 11. Signed informed consent Exclusion Criteria: 1. Symptomatic brain metastasis 2. Active another neoplasms 3. Severe SVC syndrome 4. Massive pericardial, pleural effusion, or ascites 5. Bone metastasis emergent for palliative radiotherapy or surgery 6. Uncontrollable systemic hypertension 7. Heart failure, Unstable angina, Myocardial infarction within 6 months 8. Uncontrollable diabetes 9. Active infection 10. Interstitial pneumonia/ Pulmonary fibrosis 11. Hypersensitivity for polysorbate 80 12. Systemic administration of corticosteroids

Locations (29)

Outcomes

Primary Outcomes

overall survival

Secondary Outcomes

Toxicity

Progression-free survival

Response rate

Symptom score

Data from ClinicalTrials.gov

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Aichi Cancer Center Hospital

Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan

Aichi Cancer Center,Aichi Hospital

Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama,Horinouchi,13, Ehime, Japan

Kyushu University Hospital

Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan

Gifu Municipal Hospital

Gifu,Kashima-cho,7-1, Gifu, Japan

Gunma Prefectural Cancer Center

Ota,Takabayashi-nishi-cho,617-1, Gunma, Japan

National Nishigunma Hospital

Shibukawa,Kanai,2854, Gunma, Japan

National Hospital Organization, Dohoku National Hospital

Asahikawa,Hanasaki,7-4048, Hokkaido, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan

...and 19 more locations