Clinical trial NCT04380480: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: esophageal squamous cell carcinoma
percutaneous endoscopic gastrostomy
concurrent chemoradiotherapy
enteral nutrition support
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Recent Weight Loss
timeFrame: From baseline until the end of concurrent chemoradiotherapy, an average of 8 weeks
Secondary outcomes:
measure: Change in nutrition status assessed by blood test
timeFrame: 1 year
measure: Quality of life measured by WHO Quality of Life-100 questionnaire
timeFrame: 1 year
measure: Rate of grade 3-4 radiation esophagitis
timeFrame: 1 year
measure: Rate of grade 3-4 radiation pneumonitis，
timeFrame: 1 year
measure: Rate of grade 3-4 bone marrow suppression
timeFrame: 1 year
measure: Objective response rate
timeFrame: 2 months
measure: Overall survival
timeFrame: 3 years
measure: Changes of participants' intestinal flora assessed by blood, urine and stool test
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hui Liu
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hui Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
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