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A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly gemcitabine in elder patients (> 75) with previously untreated advanced non-small cell lung cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (> 76 years) who have received no prior treatment for non-small lung cancer. As secondary objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin combination chemotherapy, progression-free survival and overall survival will be evaluated in both patients with biweekly gemcitabine and carboplatin combination chemotherapy and weekly single gemcitabine.
The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus carboplatin may improve the efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Gemcitabine 1000mg/m2 Day 1,15 Carboplatin AUC=3 Day 1, 15 every 4 weeks |
|
| 2 | Active Comparator | Gemcitabine 1000mg/m2 Day 1, 8, 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine and carboplatin | Drug | Gemcitabine 1000mg/m2, DIV on day 1 and 15 of each 28 day cycle. Carboplatin AUC=3, DIV on day 1 and 15 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops, up to 6 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy (response rate) | two-years, followed RECIST criteria |
| Measure | Description | Time Frame |
|---|---|---|
| The toxicity profile (adverse event profile) | two-years, followed NCI-CTCAE criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kingo Chida, MD,PhD | Hamamatsu University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamamatsu University School of Medicine | Hamamatsu | Shizuoka | 431-3192 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22705118 | Derived | Kusagaya H, Inui N, Karayama M, Nakamura Y, Kuroishi S, Yokomura K, Toyoshima M, Shirai T, Masuda M, Yamada T, Yasuda K, Suda T, Chida K. Biweekly combination therapy with gemcitabine and carboplatin compared with gemcitabine monotherapy in elderly patients with advanced non-small-cell lung cancer: a randomized, phase-II study. Lung Cancer. 2012 Sep;77(3):550-5. doi: 10.1016/j.lungcan.2012.05.106. Epub 2012 Jun 15. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine | Drug | Gemcitabine 1000mg/m2, DIV on day 1, 8 and 15 of each 28 day cycle. Number of cycles: until progression or unacceptable toxicity develops, up to 6 cycles |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |