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The treatment of squamous cell carcinoma of lung has not improved suffuciently. Nedaplatin is a second-generation platinum compound that is more active against squamous cell carcinoma of the lung with a response rate of 60%, issued by the finished Phase II trial in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | experimental group: Nedaplatin((80 mg/m2, i.v Day1)in combination with Docetaxel(75 mg/m2, i.v Day1)for each cycle, 4 cycles in total. |
|
| comparative group | Active Comparator | comparative group:Cisplatin ((75 mg/m2, i.v Day1 or 25 mg/m2 Day1-3)in combination with Docetaxel(75 mg/m2, i.v Day1)for each cycle, 4 cycles in total |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nedaplatin | Drug |
| ||
| Cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| progress free survival | after being enrolled, the subjects will be subject to 4 cycles chemotherapy (each cycle: 21 days). if complete response/partial response/stable desease is confirmed, the subjects will be followed up till to the sixth months. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | the effectiveness will be evaluated after 2 cycles of chemotherapy is finished. 4 cycles of chemotherapy is needed for each subject. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse Events will be recorded and monitored till to normal or basal level achieved. | 10 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Xiangya Hospital | Changsha | Hunan | China | |||
| Nanjing Military General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30017831 | Derived | Lu S, Chen Z, Hu C, Zhang J, Chen Y, Song Y, Zhao Q, Fan Y, Wu G, Ma Z, Fang J, Yu Q, Liu Z. Nedaplatin Plus Docetaxel Versus Cisplatin Plus Docetaxel as First-Line Chemotherapy for Advanced Squamous Cell Carcinoma of the Lung - A Multicenter, Open-label, Randomized, Phase III Trial. J Thorac Oncol. 2018 Nov;13(11):1743-1749. doi: 10.1016/j.jtho.2018.07.006. Epub 2018 Jul 11. |
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C053989 | nedaplatin |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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|
| Docetaxel | Drug |
|
| Nanjing |
| Jiangsu |
| China |
| Shanghai Chest hospital | Shanghai | Shanghai Municipality | 200000 | China |
| Xijing Hospital | Xian | Shanxi | China |
| D018307 |
| Neoplasms, Squamous Cell |
| D043823 |
| Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |