CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomycombination
Likely dose
Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy 1.5gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04380480
NCT04380480Phase 2Completed
CompareCT.gov

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

Sun Yat-sen University·interventional·Posted May 8, 2020·Updated Jan 11, 2023

In Brief

A Phase 2 clinical trial evaluating Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy for Esophageal Squamous Cell Carcinoma. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEsophageal Squamous Cell Carcinoma
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 8, 2020
Enrollment StartFeb 1, 2020
Primary CompletionMar 15, 2022
TodayJul 1, 2026
Enrollment to primary: 2.1 yearsPosted 6.1 years ago

Interventions

Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomycombination

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.