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

January 10, 2023 updated by: Hui Liu, Sun Yat-sen University

A Prospective, Phase II Study of Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy in Patients With Esophageal Squamous Cell Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Hui Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Recent Weight Loss
Time Frame: From baseline until the end of concurrent chemoradiotherapy, an average of 8 weeks
From baseline until the end of concurrent chemoradiotherapy, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
3 years
Objective response rate
Time Frame: 2 months
2 months
Change in nutrition status assessed by blood test
Time Frame: 1 year
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
Time Frame: 1 year
1 year
Rate of grade 3-4 radiation esophagitis
Time Frame: 1 year
1 year
Rate of grade 3-4 radiation pneumonitis，
Time Frame: 1 year
1 year
Rate of grade 3-4 bone marrow suppression
Time Frame: 1 year
1 year
Changes of participants' intestinal flora assessed by blood, urine and stool test
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

March 21, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-1059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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