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This Phase II randomized study is to determine the efficacy of percutaneous endoscopic gastrostomy before definitive concurrent chemoradiotherapy (CCRT) in Patients with Esophageal Squamous Cell Carcinoma(ESCC) by assessing their weight, nutritional status, performance status and treatment response.
This Phase II randomized study is to determine the efficacy of percutaneous endoscopic gastrostomy before definitive concurrent chemoradiotherapy (CCRT) in Patients with Esophageal Squamous Cell Carcinoma(ESCC) by assessing their weight, nutritional status, performance status and treatment response.
All patients will receive definitive radiotherapy combined with three cycles of S-1 (40mg/2, BID, po) on D1-14, D22-35, D43-56. The primary endpoint is percentage of recent weight loss at the end of CCRT. The secondary endpoints are nutrition status, objective response rate, overall survival, toxicity and intestinal flora changes in blood, urine and stool specimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experiment | Experimental | One or two weeks before CCRT, all patients will undergo a percutaneous endoscopic gastrostomy (PEG) to be administered enteral nutrition support(30-35 kcal/kg of energy, 1.2-1.5g/kg of protein and electrolyte supplementation each day). Nutritional supplements will be administered till 1 month after CCRT. All patients will receive definitive radiotherapy combined with three cycles of S-1 (40mg/2, BID, po) on D1-14, D22-35, D43-56. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy | Combination Product | One or two weeks before CCRT, all patients will undergo a percutaneous endoscopic gastrostomy (PEG) to be administered enteral nutrition support(30-35 kcal/kg of energy, 1.2-1.5g/kg of protein and electrolyte supplementation each day). Nutritional supplements will be administered till 1 month after CCRT. All patients will receive definitive radiotherapy combined with three cycles of S-1 (40mg/2, BID, po) on D1-14, D22-35, D43-56. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Recent Weight Loss | From baseline until the end of concurrent chemoradiotherapy, an average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nutrition status assessed by blood test | Change in nutrition status will be assessed by hemoglobin, serum albumin, pre-albumin test. The patient-generated subjective global assessment will also be used to measure patients' nutrition status | 1 year |
| Quality of life measured by WHO Quality of Life-100 questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Liu, Ph.D | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hui Liu | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25651787 | Background | Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4. | |
| 10235156 | Background | Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623. |
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|
| 1 year |
| Rate of grade 3-4 radiation esophagitis | 1 year |
| Rate of grade 3-4 radiation pneumonitis， | 1 year |
| Rate of grade 3-4 bone marrow suppression | 1 year |
| Objective response rate | 2 months |
| Overall survival | 3 years |
| Changes of participants' intestinal flora assessed by blood, urine and stool test | 1 year |
| 22314972 | Background | Bozzetti F, Mariani L, Lo Vullo S; SCRINIO Working Group; Amerio ML, Biffi R, Caccialanza G, Capuano G, Correja I, Cozzaglio L, Di Leo A, Di Cosmo L, Finocchiaro C, Gavazzi C, Giannoni A, Magnanini P, Mantovani G, Pellegrini M, Rovera L, Sandri G, Tinivella M, Vigevani E. The nutritional risk in oncology: a study of 1,453 cancer outpatients. Support Care Cancer. 2012 Aug;20(8):1919-28. doi: 10.1007/s00520-012-1387-x. |
| 23106980 | Background | Clavier JB, Antoni D, Atlani D, Ben Abdelghani M, Schumacher C, Dufour P, Kurtz JE, Noel G. Baseline nutritional status is prognostic factor after definitive radiochemotherapy for esophageal cancer. Dis Esophagus. 2014 Aug;27(6):560-7. doi: 10.1111/j.1442-2050.2012.01441.x. Epub 2012 Oct 26. |
| 28077159 | Background | Ma L, Luo GY, Ren YF, Qiu B, Yang H, Xie CX, Liu SR, Liu SL, Chen ZL, Li Q, Fu JH, Liu MZ, Hu YH, Ye WF, Liu H. Concurrent chemoradiotherapy combined with enteral nutrition support: a radical treatment strategy for esophageal squamous cell carcinoma patients with malignant fistulae. Chin J Cancer. 2017 Jan 11;36(1):8. doi: 10.1186/s40880-016-0171-6. |
| 28279472 | Background | Birnstein E, Schattner M. Nutritional Support in Esophagogastric Cancers. Surg Oncol Clin N Am. 2017 Apr;26(2):325-333. doi: 10.1016/j.soc.2016.10.003. Epub 2017 Feb 9. |
| 29225081 | Background | Yu FJ, Shih HY, Wu CY, Chuang YS, Lee JY, Li HP, Fang PT, Tsai DL, Chou SH, Wu IC. Enteral nutrition and quality of life in patients undergoing chemoradiotherapy for esophageal carcinoma: a comparison of nasogastric tube, esophageal stent, and ostomy tube feeding. Gastrointest Endosc. 2018 Jul;88(1):21-31.e4. doi: 10.1016/j.gie.2017.11.030. Epub 2017 Dec 7. |
| 16813813 | Background | Lin CH, Liu NJ, Lee CS, Tang JH, Wei KL, Yang C, Sung KF, Cheng CL, Chiu CT, Chen PC. Nasogastric feeding tube placement in patients with esophageal cancer: application of ultrathin transnasal endoscopy. Gastrointest Endosc. 2006 Jul;64(1):104-7. doi: 10.1016/j.gie.2005.12.036. |
| 14602314 | Background | Margolis M, Alexander P, Trachiotis GD, Gharagozloo F, Lipman T. Percutaneous endoscopic gastrostomy before multimodality therapy in patients with esophageal cancer. Ann Thorac Surg. 2003 Nov;76(5):1694-7; discussion 1697-8. doi: 10.1016/s0003-4975(02)04890-7. |
| 27188297 | Background | Sofue K, Takeuchi Y, Tsurusaki M, Shibamoto K, Sakamoto N, Kitajima K, Sone M, Sugimura K, Arai Y. Value of Percutaneous Radiologic Gastrostomy for Patients with Advanced Esophageal Cancer. Ann Surg Oncol. 2016 Oct;23(11):3623-3631. doi: 10.1245/s10434-016-5276-2. Epub 2016 May 17. |
| 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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