Status:
COMPLETED
Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 Carci...
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 Carci...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04380480
Start Date
February 1 2020
End Date
March 15 2022
Last Update
January 11 2023
Active Locations (1)
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1
Hui Liu
Guangzhou, Guangdong, China, 510000