Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Prospective, Multicenter, Randomized Controlled Study to Compare Chemoradiotherapy With or Without Enteral Nutrition Intervention for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399306
• Other study ID #: scch2015001
• Status: Completed
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: October 2017

Study information

• Verified date: March 2020
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, prospective, multicenter study.

Description:

This is a randomized, prospective, multicenter study. The aim of this study was to compare the changes of body weight,survival,toxicity,quality of life and opportunistic infection frequency in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma between and after chemoradiotherapy with or without enteral nutrition therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 to 75 years old

• male or femalePathologically or cytologically proven esophageal squamous cell carcinoma

• Clinical stage II or stage III

• PG-SGA?2

• Karnofsky performance score(KPS) ?70

• Estimated life expectancy of at least 12 weeks

• Hemoglobin=90.0g/dL,white blood cell count(WBC)= 4000 cells/mm³,Platelet count=100,000 cells/mm³

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal

• Creatinine normal OR creatinine clearance = 60 mL/min

• Patients have good compliance to treatment and follow-up of acceptance

• Forced expiratory volume in one second(FEV1) = 1.5 litre or = 75% of the reference value

• the functions of the heart, kidney, liver were basically normal, with no chemotherapy and radiotherapy contraindications

Exclusion Criteria:

• Patients with severely bowel function impaired or can not tolerate enteral nutrition

• Patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted

• Patients have no risk of malnutrition

• Patients have severe malnutrition (weight loss >10% or <30 g/L, BMI<18.5 kg/m2 or hemoglobin<90 g/L before the treatment

• Patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction

• Patients can not tolerate chemotherapy and radiotherapy

• Patients who have distant metastasis

• The primary tumor or lymph node already received surgical treatment (except for biopsy);

• Patient who received radiotherapy for primary tumor or lymph node;

• Patient who received chemotherapy or immunotherapy;

• Patient who suffered from other malignant tumor;

• Patient who have taken other drug test within 1 month;

• Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;

• Subject with a severe allergic history or idiosyncratic;

• Subject with severe pulmonary and cardiopathic disease history;

• Refuse or incapable to sign the informed consent form of participating this trial;

• Drug abuse or alcohol addicted;

• Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Chemoradiotherapy
• Enteral Nutrition Therapy
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Enteral nutrition
Patients in the Trial Group received concurrent chemoradiotherapy and standardized, whole-course enteral nutrition management.

Radiation:
• radiotherapy
Patients receive intensity modulated radiation therapy(IMRT) from week 1 to week 7,once a day, 5 times per week. Radiotherapy dose:95% gross tumor volume(GTV-T) 60-66 Gy /30-33f,GTV-N 60-66 Gy /30-33f,CTV-T 50-54 Gy /25-27f,CTV-N 50-54 Gy /25-27f.

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital & Institute	Chengdu	Sichuan

Sponsors (8)

Lead Sponsor	Collaborator
Sichuan Cancer Hospital and Research Institute	Beijing Cancer Hospital, Hebei Medical University Fourth Hospital, Henan Cancer Hospital, Shandong Tumor Hospital, Shanxi Province Cancer Hospital, Wuhan University, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight Change from baseline to the end of treatment	Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight.	up to 1 month after the treatment
Secondary	Maximum Body Weight Change during treatment	Maximum body weight change during treatment= the lowest body weight during treatment - baseline body weight.	up to 1 month after the treatment
Secondary	Blood biochemical examination	albumin, haemoglobin,et al	up to 1 month after the treatment
Secondary	Grade 3-5 toxicity	Grade 3-5 adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 andthe criteria of the Radiation Therapy Oncology Group ,such as esophagitis?pneumonitis ?hematologic toxicity and infection rate	up to 1 month after the treatment
Secondary	Completion rate of chemoradiotherapy	The proportion of people who complete all treatment as required	up to 1 month after the treatment
Secondary	short-term effect	objective remission rate	up to 1 month after the treatment
Secondary	Overall Survival	overall survival	at least 2 years