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NCT Number: NCT04380480

Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for 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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hui Liu

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Recent Weight Loss

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

Secondary outcomes

  1. 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

  2. Quality of life measured by WHO Quality of Life-100 questionnaire

    Time frame: 1 year

  3. Rate of grade 3-4 radiation esophagitis

    Time frame: 1 year

  4. Rate of grade 3-4 radiation pneumonitis，

    Time frame: 1 year

  5. Rate of grade 3-4 bone marrow suppression

    Time frame: 1 year

  6. Objective response rate

    Time frame: 2 months

  7. Overall survival

    Time frame: 3 years

  8. Changes of participants' intestinal flora assessed by blood, urine and stool test

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 8, 2020
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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