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| Name | Class |
|---|---|
| Hebei Medical University Fourth Hospital | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| Anyang Tumor Hospital | OTHER |
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This phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIB-IMRT combined chemotherapy followed by chemotherapy | Active Comparator | SIB-IMRT: 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. Concurrent chemotherapy: Paclitaxel and platinum based drug are administered once a week for at least 5 weeks during radiotherapy treatment days. |
|
| SIB-IMRT Alone followed by chemotherapy | Placebo Comparator | SIB-IMRT: 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIB-IMRT | Radiation | PTV:50.4Gy/28f, PGTV:59.92Gy/28f |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival（OS） | 1 year | |
| Overall survival（OS） | 2 year | |
| Overall survival（OS） | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival（PFS） | 1 year | |
| Progress free survival（PFS） | 2 year | |
| Progress 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 | |
| Xiao Chang, MD | Contact | +86-18801067622 | changxiaojlu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zefen Xiao, MD | The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science | Principal Investigator |
| 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 | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32962674 | Derived | Gao LR, Wang X, Han W, Deng W, Li C, Wang X, Zhao Y, Ni W, Chang X, Zhou Z, Deng L, Wang W, Liu W, Liang J, Zhang T, Bi N, Wang J, Zhai Y, Feng Q, Lv J, Li L, Xiao Z. A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy in patients with esophageal cancer: 3JECROG P-02 study protocol. BMC Cancer. 2020 Sep 22;20(1):901. doi: 10.1186/s12885-020-07387-y. |
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| The First Affiliated Hospital with Nanjing Medical University |
| OTHER |
| Affiliated Hospital of Hebei University | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| Sichuan Cancer Hospital and Research Institute | OTHER |
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| Paclitaxel | Drug | 45-50 mg/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 | 150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy |
|
| Platinum-Based Drug | Drug | Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy |
|
| 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 | the completion rate of each arm | up to 2 year |
| Adverse events | up to 5 year |
|
| 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 |
|---|---|
| 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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