CompletedPhase 2

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

China63 participantsStarted 2020-02-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Recent Weight Loss

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

Trial details

NCT IDNCT04380480

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-15

View on ClinicalTrials.gov More Esophageal Squamous Cell Carcinoma trials