Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for Esophageal Squamous Cell Carcinoma

NCT04380480 | Completed Phase 2

• 1 other identifier: GASTO-1059
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

esophageal squamous cell carcinoma; percutaneous endoscopic gastrostomy; concurrent chemoradiotherapy; enteral nutrition support

Outcome Measures

Primary Outcomes (1)

• Percentage of Recent Weight Loss

  From baseline until the end of concurrent chemoradiotherapy, an average of 8 weeks

Secondary Outcomes (8)

• Change in nutrition status assessed by blood test

  1 year

• Quality of life measured by WHO Quality of Life-100 questionnaire

  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

Study Arms (1)

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.

Combination Product: Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy

Interventions

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.

Experiment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed esophageal squamous cell carcinoma
• 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

You may not qualify if:

• Severe gastrointestinal impairment or enteral nutrition intolerance
• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Hui Liu

Guangzhou, Guangdong, 510000, China

Location

Related Publications (10)

• 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.

  PMID: 25651787 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.

  PMID: 10235156 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. Erratum In: Support Care Cancer. 2012 Aug;20(8):1929. Capuano, Giovanni [corrected to Capuano, Giorgio].

  PMID: 22314972 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.

  PMID: 23106980 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.

  PMID: 28077159 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.

  PMID: 28279472 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.

  PMID: 29225081 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.

  PMID: 16813813 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.

  PMID: 14602314 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.

  PMID: 27188297 BACKGROUND

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Hui Liu, Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: May 8, 2020
• Study Start: February 1, 2020
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)