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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Non-Small Cell Lung Cancer(NSCLC) is the leading cause of death in Korean men after stomach cancer. Surgical resection plays a main role for curative treatment. However, less than 20 % of the NSCLC patients have been found in stage I-II disease. In inoperable stage IIIA/B disease, the recommended treatment is combined chemotherapy and radiation therapy. Various kinds of combination of 2 modalities have been used either in sequential or concurrent setting. Concurrent chemoradiotherapy(CCRT) have been recognized to have better survival than radiation therapy alone or sequential therapy, but additional consolidation chemotherapy after CCRT is not yet to be determined for the beneficial role in survival gain. Docetaxel is an anticancer drug and has synergistic anticancer effect in various cancer with cisplatin, another anticancer drug. In the present study, randomised trial will be performed to confirm the efficacy of the consolidation chemotherapy with docetaxel and cisplatin after completing CCRT with the same chemotherapeutic agents in stage III inoperable NSCLC on progression free survival and overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCRT arm without consolidation chemotherapy | Active Comparator | Docetaxel 20mg/m2 & Cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy |
|
| CCRT arm with consolidation chemotherapy | Experimental | docetaxel 20mg/m2 & cisplatin 20mg/m2 (D1,8,15,22,29,36) during radiotherapy, and followed by consolidation chemotherapy with 3-weekly docetaxel 35mg/m2 & cisplatin 35mg/m2 (D1,8) every 3 weeks (#3). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| consolidation chemotherapy with Docetaxel plus cisplatin | Drug | definitive CCRT, and followed by consolidation chemotherapy with three cycles of docetaxel plus cisplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | The final analysis will be conducted when 381 events (progressions or deaths) are observed. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | The final analysis will be conducted when 381 events (progressions or deaths) are observed. | |
| response rate | The final analysis will be conducted when 381 events (progressions or deaths) are observed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keunchil Park, M.D. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26150444 | Derived | Ahn JS, Ahn YC, Kim JH, Lee CG, Cho EK, Lee KC, Chen M, Kim DW, Kim HK, Min YJ, Kang JH, Choi JH, Kim SW, Zhu G, Wu YL, Kim SR, Lee KH, Song HS, Choi YL, Sun JM, Jung SH, Ahn MJ, Park K. Multinational Randomized Phase III Trial With or Without Consolidation Chemotherapy Using Docetaxel and Cisplatin After Concurrent Chemoradiation in Inoperable Stage III Non-Small-Cell Lung Cancer: KCSG-LU05-04. J Clin Oncol. 2015 Aug 20;33(24):2660-6. doi: 10.1200/JCO.2014.60.0130. Epub 2015 Jul 6. |
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| CCRT arm without consolidation chemotherapy | Drug | definitive CCRT with weekly Docetaxel/CDDP #6 without consolidation chemotherapy |
|
| patterns of failure | The final analysis will be conducted when 381 events (progressions or deaths) are observed. |
| safety | The final analysis will be conducted when 381 events (progressions or deaths) are observed. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D060830 | Consolidation Chemotherapy |
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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