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This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.
This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab combined with chemoradiotherapy for unresectable,locally advanced squamous cell lung cancer.
All patients were planned to receive radical dose of chest radiation and concurrent chemotherapy of weekly docetaxel and cisplatin, each of 1 day's duration.
Nimotuzumab group was treated with weekly nimotuzumab (200mg, IV) combined with chemoradiotherapy, while control group was treated with chemoradiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab | Experimental | Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab. |
|
| Control | Active Comparator | Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | 3 years | |
| progression-free survival | 3 years | |
| rate of grade 3-4 radiation esophagitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Liu, Professor | Sun yat-sen universtiy cancer center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| 7580546 | Background | Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Non-small Cell Lung Cancer Collaborative Group. BMJ. 1995 Oct 7;311(7010):899-909. |
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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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| docetaxel and cisplatin | Drug | Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy |
|
| daily RT to the chest | Radiation | Patients received daily RT to the chest |
|
rate of grade 3-4 radiation esophagitis as assessed by CTCAE v4.0 |
| 1 years |
| rate of grade 3-4 radiation pneumonitis | rate of grade 3-4 radiation pneumonitis as assessed by CTCAE v4.0 | 1 year |
| Failure patterns | rates of local-regional recurrence, distant metastasis and brain metastasis | 3 years |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |