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Most local failures after definitive chemoradiation for unresectable esophageal cancer occur in the gross tumor volume (GTV). And the metabolic active areas post-treatment were located in the high FDG uptake areas prior to the radiotherapy. The hypothesis is that selective dose boost to the esophageal GTV could be safely delivered using a simultaneous integrated boost (SIB) technique, and that boosting the high 18F-deoxyglucose (FDG) uptake areas of the esophageal GTV defined prior to treatment may improve local tumor control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiotherapy+chemotherapy | Experimental | Radiotherapy: LEVEL 1: dose given at PTV-G and PTV-C will be 64Gy/32 fractions and 50Gy/25 fractions. LEVEL 2: dose given at PTV-G and PTV-C will be 63Gy/28 fractions and 50.4Gy/28 fractions. LEVEL 3: dose given at PTV-GR (with an integrated boost to the 50% SUVmax area of the primary tumor of the pre-treatment 18FDG-PET/CT scan), PTV-G and PTV-C will be 70Gy/28 fractions, 63Gy/28 fractions and 50.4Gy/28 fractions. LEVEL 4: dose given at PTV-GR (with an integrated boost to the 50% SUVmax area of the primary tumor of the pre-treatment 18FDG-PET/CT scan), PTV-G and PTV-C will be 70Gy/25 fractions, 62.5Gy/25 fractions and 50Gy/25 fractions. Chemotherapy: Concurrent chemotherapy: Cisplatin 25mg/m2 IV daily on Days 1-3 and 29-31 plus 5-FU 500mg/m2 IV continuous infusion over 24 hours daily on Days 1-4 and 29-32. Consolidation chemotherapy: Cisplatin 25mg/m2 IV daily on Days 1-3 plus 5-FU 600mg/m2 IV daily on Days 1-5, cycled every 4 weeks for 2 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Patients will receive from 5 to 6 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity(DLT) | 3 months after the finish of the radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 3 years | |
| Progression-free survival (PFS) | 3 years | |
| Failure patterns |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrent rate within the >50% SUVmax region of the primary tumor | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen Yu, MD, PHD | Contact | 8621-64175590 | 1505 | yuzhiwen0827@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaolong Fu, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25586952 | Derived | Yu W, Cai XW, Liu Q, Zhu ZF, Feng W, Zhang Q, Zhang YJ, Yao ZF, Fu XL. Safety of dose escalation by simultaneous integrated boosting radiation dose within the primary tumor guided by (18)FDG-PET/CT for esophageal cancer. Radiother Oncol. 2015 Feb;114(2):195-200. doi: 10.1016/j.radonc.2014.12.007. Epub 2015 Jan 10. |
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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 |
|---|---|
| D011878 | Radiotherapy |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Chemotherapy (5-FU+DDP) | Drug | Patients will receive 2 cycles of concurrent chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 and 29-31 plus 5-FU 500mg/m2 IV continuous infusion over 24h daily on Days 1-4 and 29-32) during radiotherapy period. Consolidation chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 plus 5-FU 600mg/m2 IV daily on Days 1-5, cycled every 4 weeks) will be given for 2 cycles one month after the end of radiochemotherapy. |
|
| 3 years |
| Late toxicity | Esophageal perforation, esophageal bleeding or late radiation-induced lung or heart injury of grade 3 or above(CTCAE3.0) | 3 years |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |