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To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also planned.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel | Experimental | Patients received pemetrexed 500mg/m2 days 1,29+cisplatin 25 mg/m2 days 1-3,29-31 + Radiation 6000 cGy (200 cGy/day). Patients with complete response(CR), partial response(PR) or stable disease(SD) with manageable toxicity received docetaxel 60 mg/m2 days 57,78. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | Pemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 3 years | |
| Local control rate | 3 years | |
| The short-term quality of life (QOL) assessed using FACT-E score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shenglin Ma, MD | Contact | 0571-56007908 | 086 | mashenglin@medmail.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 310006 | China |
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| cisplatin | Drug | Cisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles |
|
|
| thoracic radiation therapy | Radiation | Chemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin |
|
| docetaxel | Drug | Docetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles |
|
|
FACT-E score at the 4 months after docetaxel consolidation therapy |
| 4 months |
| Rate of CTCAE grade 2 or higher radiation pneumonitis | The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy | 1 years |
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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