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This study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not.
For the esophageal carcinoma in II~III stage, routine dosage of Paclitaxel and platinum medicine chemotherapy concurrently radical radiotherapy is worthy to be studied. On this base, we advanced approach the enlarged field radiotherapy and the intervention of Tarceva. And we approach the therapeutic effect for this method theoretically, which may give a further reasonable guidance for the clinical therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Enlarged field + Paclitaxel + Cisplatin + Tarceva |
|
| B | Experimental | Enlarged field + Paclitaxel + Cisplatin |
|
| C | Active Comparator | Conventional field + Paclitaxel + Cisplatin + Tarceva |
|
| D | Active Comparator | Conventional field + Paclitaxel + Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | 135mg/m2, day 1 and day 29 of the radiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | failure: death from any cause | five years after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Failure: occurrence of local or regional progression, distant metastases, or death from any cause | five years after enrollment |
| local-regional control rate | Failure: occurrence of local or regional progression |
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Inclusion Criteria:
Exclusion Criteria:
(1)Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2)A history of myocardial infarction in the past 6 months; (3)There is a need for antibiotic treatment of acute bacterial or fungal infection; (4)Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5)Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6)Uncontrollable seizures, or loss of insight because of mental illness
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shixiu Wu, MD | Contact | 86-0577-8806-9372 | wushixiu@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shixiu Wu, MD | 1st affliated hospital of Wen Zhou Medical college | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st affliated hospital of Wen Zhou Medical college | Recruiting | Wenzhou | Zhejiang | 325000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32958820 | Derived | Xie C, Jing Z, Luo H, Jiang W, Ma L, Hu W, Zheng A, Li D, Ding L, Zhang H, Xie C, Lian X, Du D, Chen M, Bian X, Tan B, Xia B, Xie R, Liu Q, Wang L, Wu S. Chemoradiotherapy with extended nodal irradiation and/or erlotinib in locally advanced oesophageal squamous cell cancer: long-term update of a randomised phase 3 trial. Br J Cancer. 2020 Nov;123(11):1616-1624. doi: 10.1038/s41416-020-01054-6. Epub 2020 Sep 22. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D000069347 | Erlotinib Hydrochloride |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Cisplatin | Drug | 20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy. |
|
| Tarceva | Drug | 150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy) |
|
|
| Radiotherapy | Radiation | Enlarged field radiotherapy |
|
| Radiotherapy | Radiation | Conventional field radiotherapy |
|
| three years after enrollment |
| Adverse events | assessed by RTOG Acute Radiation Morbidity Scoring Criteria and RTOG/EORTC Late Radiation Morbidity Scoring Schema | five years after enrollment |
| Health-related quality of life | assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E) | five years after enrollment |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal 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 |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |