Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

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.

Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy

Hui Liu, Ph.D

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.

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.

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

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

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

Sun Yat-sen University

Professor

Symptoms and General Pathology

Neoplasm Metastasis

In this group the participants will be examined by white light endoscopy first and secondly with blue laser imaging technique during the same gastroscopy.

In this group the participants will be examined by blue laser imaging technique first and secondly with standard white light during the same gastroscopy.

The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.

blue laser imaging

Mireen Friedrich-Rust, Professor

This study wants to focus on Carcinoma detection rates with blue laser imaging (BLI) for participants with head-neck cancer who need a percutaneous endoscopic gastrostomy (PEG). BLI is a new imaging technique that can easily be used within a standard gastroscopy.

Head-Neck cancers are a significant burden all around the world. Patients suffering from one tumor are at high risk for a second cancer or another precancerous lesion. Before or during cancer treatment a PEG is needed to maintain a sufficient calories intake. PEG is established by performing a standard gastroscopy.

This randomised study wants to compare the detection rates of standard white light endoscopy compared to the additional use of blue laser imaging for second cancers or precancerous lesions in participants presenting for PEG establishment.

This study is a prospective randomised mono centric study with a one to one allocation in two different treatment arms.

The participants don't know which arm they were allocated to.

Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer

Detection Rate by Blue Laser Imaging (BLI) of Secondary or Early Squamous Head and Neck Cancer in Patients Undergoing Elective Percutaneous Endoscopic Gastrostomy (PEG)

The detection rates for malignant or premalignant lesions in participants with head neck tumors will be compared when using BLI and white light endoscopy

Georg Dultz

Record Keeper

Adenoma

Stomach Neoplasms

Stomach Cancer

Coagulants

All Drugs and Chemicals

Dermatologic Agents

Hemostatics

Menthol

Patients who require therapeutic upper gastrointestinal endoscopy, such as polypectomy, endoscopic hemostasis, percutaneous endoscopic gastrostomy (PEG), endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will receive an intragastric spraying of NPO-11. The efficacy of NPO-11 as an anti-peristaltic agent for the endoscopic therapeutic procedures will be evaluated based on the proportion of patients with suppressed gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by an independent committee.

The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.

Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy

No or mild gastric peristalsis is defined as when patients have no or suppressed gastric peristalsis during the therapeutic procedure (for 45 s). The degree of gastric peristalsis in the time periods is assessed by an independent committee.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for Esophageal Squamous Cell Carcinoma	NCT04380480	Esophageal Squa...	Concurrent chem...	18 Years - 75 Years	Sun Yat-sen University
Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer	NCT04566367	Head Neck Cance... Esophageal Canc... Gastrostomy	blue laser imag...	18 Years -	Johann Wolfgang Goethe University Hospital
Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy	NCT01411189	Gastric Cancer Colon Nos Polyp... Gastric Adenoma	Menthol	20 Years -	Nihon Pharmaceutical Co., Ltd
Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for Esophageal Squamous Cell Carcinoma	NCT04380480	Esophageal Squa...	Concurrent chem...	18 Years - 75 Years	Sun Yat-sen University
Percutaneous Endoscopic Gastrostomy Before Definitive Concurrent Chemoradiation Therapy for Esophageal Squamous Cell Carcinoma	NCT04380480	Esophageal Squa...	Concurrent chem...	18 Years - 75 Years	Sun Yat-sen University
Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy	NCT01411189	Gastric Cancer Colon Nos Polyp... Gastric Adenoma	Menthol	20 Years -	Nihon Pharmaceutical Co., Ltd
Blue Laser Imaging (BLI) for Detection of Secondary Head and Neck Cancer	NCT04566367	Head Neck Cance... Esophageal Canc... Gastrostomy	blue laser imag...	18 Years -	Johann Wolfgang Goethe University Hospital

Spots Global Cancer Trial Database for percutaneous endoscopic gastrostomy