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The goal of this study is to find the maximum tolerable dose of radiation that can be delivered with concurrent chemotherapy (carboplatin & paclitaxel) in patients with esophageal cancer.
Concurrent chemoradiotherapy is the standard of care for esophageal cancer based on the results of phase III randomised trials. The current standard radiation therapy dose has remained 50 Gy at -2 Gy/fraction for decades.However, locoregional control remain problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the combined modality approach. New regimen is urgently needed for improving localregional control and survival.Investigators hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (PET) /computed tomography (CT) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiochemotherapy 1 | Experimental | Patients will be treated with radiation therapy 57.2 Gy. |
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| radiochemotherapy 2 | Experimental | Patients will be treated with radiation therapy 64.4 Gy. |
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| radiochemotherapy 3 | Experimental | Patients will be treated with radiation therapy 71.6 Gy. |
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| radiochemotherapy 4 | Experimental | Patients will be treated with radiation therapy 78.8 Gy. |
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| radiochemotherapy 5 | Experimental | Patients will be treated with radiation therapy 86 Gy. |
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| radiochemotherapy 6 | Experimental | Patients will be treated with radiation therapy 93.2 Gy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiochemotherapy 1 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | Maximum Tolerated Dose is defined as CTCAE 4 grade 3 acute radiation-related toxicity | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Local Failure | Local control will be assessed radiographically using endoscopy with biopsy and a positron emission computed tomography-CT scan | 2 years |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tingfeng Chen, MD | the ethic committee of shanghai genernal hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Genernal Hospital | Shanghai | China |
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| radiochemotherapy 2 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; |
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| radiochemotherapy 3 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; |
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| radiochemotherapy 4 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; |
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| radiochemotherapy 5 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; |
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| radiochemotherapy 6 | Radiation | concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; |
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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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