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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring esophageal squamous cell carcinoma, percutaneous endoscopic gastrostomy, concurrent chemoradiotherapy, enteral nutrition support

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hui Liu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experiment

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Recent Weight Loss

Secondary Outcome Measures

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
Quality of life measured by WHO Quality of Life-100 questionnaire
Rate of grade 3-4 radiation esophagitis
Rate of grade 3-4 radiation pneumonitis，
Rate of grade 3-4 bone marrow suppression
Objective response rate
Overall survival
Changes of participants' intestinal flora assessed by blood, urine and stool test

Full Information

First Posted
March 21, 2020
Last Updated
January 10, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04380480
Brief Title
Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for Esophageal Squamous Cell Carcinoma
Official Title
A Prospective, Phase II Study of Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy in Patients With Esophageal Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
esophageal squamous cell carcinoma, percutaneous endoscopic gastrostomy, concurrent chemoradiotherapy, enteral nutrition support

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experiment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Recent Weight Loss
Time Frame
From baseline until the end of concurrent chemoradiotherapy, an average of 8 weeks
Secondary Outcome Measure Information:
Title
Change in nutrition status assessed by blood test
Description
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
Time Frame
1 year
Title
Quality of life measured by WHO Quality of Life-100 questionnaire
Time Frame
1 year
Title
Rate of grade 3-4 radiation esophagitis
Time Frame
1 year
Title
Rate of grade 3-4 radiation pneumonitis，
Time Frame
1 year
Title
Rate of grade 3-4 bone marrow suppression
Time Frame
1 year
Title
Objective response rate
Time Frame
2 months
Title
Overall survival
Time Frame
3 years
Title
Changes of participants' intestinal flora assessed by blood, urine and stool test
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Liu, Ph.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hui Liu
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for Esophageal Squamous Cell Carcinoma

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