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The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIB-IMRT combined chemotherapy with IFI | Experimental |
| |
| SIB-IMRT with IFI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIB-IMRT | Radiation | Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | 1 year | |
| Overall survival (OS) | 2 year | |
| Overall survival (OS) | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | 1 year | |
| Progression-free survival (PFS) | 2 year | |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Wang, MD | Contact | +86-13311583220 | beryl_wx2000@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Recruiting | Beijing | 100021 | China |
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| Paclitaxel | Drug | 45-50mg/m2, once a week, concurrent with radiotherapy for 5-6weeks |
|
| Platinum-Based Drug | Drug | Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks |
|
| Paclitaxel | Drug | 135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy |
|
| Platinum-Based Drug | Drug | Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy |
|
| Involved Field Irradiation (IFI) | Other | CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin. |
|
| 3 year |
| Local recurrence-free rate（LRFS） | 1 year |
| Local recurrence-free rate（LRFS） | 2 year |
| Local recurrence-free rate（LRFS） | 3 year |
| Completion Rate | up to 2 year |
| Adverse events | up to 5 year |
|
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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