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To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locaregionally esophageal cancer
Standard dose chemoradiotherapy (SCRT) results in poor local control for localregionally advanced esopgageal cancer patients. Most local failures occur in the gross tumor volume.[F-18]-fluorodeoxyglucose (FDG) PET/CT can identify residual metabolic disease (RMD). Hyperfractionated radiotherapy allows for delivering a higher dose without increasing late toxicity. Our previous phase I radiation dose escalation trial demonstrated that 86 Gy could be safely delivered to the RMD with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.The aim of this phase II study is to examine the efficacy of this regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose radiochemotherapy | Experimental | A total dose of 86 Gy to residual metabolic disease with concurrent chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high dose radiation therapy with concurrent chemotherapy | Radiation | standard dose of 50 Gy concurrent weekly with paclitaxel (45 mg/m2) and carboplatin (area under curve 1.5 ), immediately followed by hyperfractionated radiotherapy boost of 36 Gy in 30 fractions of 1.2 Gy to residual metabolic disease as defined by PET/CT |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival rate | survival time was measured from the date of study enrollment to the date of death or last follow-up | one year |
| Measure | Description | Time Frame |
|---|---|---|
| acute and late toxicities | Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4 | 1 year |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ningning Cheng, MD | Contact | 377985364 | 8119 | ningcnn@163.com |
| Yong Liu, MD | Contact | 37795364 | 8119 | drliuyrt@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tingfeng Chen, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | China |
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|
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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