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| Name | Class |
|---|---|
| Wuhan University | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| Shandong Tumor Hospital |
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This is a randomized, prospective, multicenter study.
This is a randomized, prospective, multicenter study. The aim of this study was to compare the changes of body weight,survival,toxicity,quality of life and opportunistic infection frequency in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma between and after chemoradiotherapy with or without enteral nutrition therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | chemoradiotherapy with Enteral Nutrition intervention |
|
| Arm B | Placebo Comparator | chemoradiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteral nutrition | Drug | Patients in the Trial Group received concurrent chemoradiotherapy and standardized, whole-course enteral nutrition management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight Change from baseline to the end of treatment | Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight. | up to 1 month after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Body Weight Change during treatment | Maximum body weight change during treatment= the lowest body weight during treatment - baseline body weight. | up to 1 month after the treatment |
| Blood biochemical examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| TAO LI, MD, PhD | Sichuan Cancer Hospital and Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital & Institute | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35280748 | Derived | Lyu J, Shi A, Li T, Li J, Zhao R, Zhu S, Wang J, Xing L, Yang D, Xie C, Shen L, Zhang H, Zhu G, Wang J, Pan W, Li F, Lang J, Shi H. Effects of Enteral Nutrition on Patients With Oesophageal Carcinoma Treated With Concurrent Chemoradiotherapy: A Prospective, Multicentre, Randomised, Controlled Study. Front Oncol. 2022 Feb 25;12:839516. doi: 10.3389/fonc.2022.839516. eCollection 2022. |
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| OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| Peking University Cancer Hospital & Institute | OTHER |
| Hebei Medical University Fourth Hospital | OTHER |
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| radiotherapy | Radiation | Patients receive intensity modulated radiation therapy(IMRT) from week 1 to week 7,once a day, 5 times per week. Radiotherapy dose:95% gross tumor volume(GTV-T) 60-66 Gy /30-33f,GTV-N 60-66 Gy /30-33f,CTV-T 50-54 Gy /25-27f,CTV-N 50-54 Gy /25-27f. |
|
albumin, haemoglobin,et al
| up to 1 month after the treatment |
| Grade 3-5 toxicity | Grade 3-5 adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 andthe criteria of the Radiation Therapy Oncology Group ,such as esophagitis、pneumonitis 、hematologic toxicity and infection rate | up to 1 month after the treatment |
| Completion rate of chemoradiotherapy | The proportion of people who complete all treatment as required | up to 1 month after the treatment |
| short-term effect | objective remission rate | up to 1 month after the treatment |
| Overall Survival | overall survival | at least 2 years |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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