Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for Esophageal Squamous Cell Carcinoma
NCT ID: NCT04380480
Last Updated: 2023-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2020-02-01
2022-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experiment
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.
Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy
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.
Interventions
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Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy
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.
Eligibility Criteria
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Inclusion Criteria
* Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Estimated life expectancy of at least 6 months
* No contraindications for chemotherapy or radiotherapy
* Patients and their family signed the informed consents
Exclusion Criteria
* Severe vomiting, gastrointestinal bleeding or intestinal obstruction
* Severe malnutrition
* Patients with contraindications for percutaneous endoscopic gastrostomy, including uncorrected coagulopathy or thrombocytopenia, varices caused by portal hypertension, or other gastric diseases
* Not suitable for this study judged by researchers
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Hui Liu
Professor
Principal Investigators
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Hui Liu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Hui Liu
Guangzhou, Guangdong, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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GASTO-1059
Identifier Type: -
Identifier Source: org_study_id
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