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

Primary Purpose

Esophageal Squamous Cell Carcinoma, Enteral Nutrition Therapy, Chemoradiotherapy

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Enteral nutrition
radiotherapy
Sponsored by
Sichuan Cancer Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Sichuan Cancer Hospital & Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A

Arm B

Arm Description

chemoradiotherapy with Enteral Nutrition intervention

chemoradiotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximum Body Weight Change during treatment
Maximum body weight change during treatment= the lowest body weight during treatment - baseline body weight.
Blood biochemical examination
albumin, haemoglobin,et al
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
Completion rate of chemoradiotherapy
The proportion of people who complete all treatment as required
short-term effect
objective remission rate
Overall Survival
overall survival

Full Information

First Posted
March 17, 2015
Last Updated
March 16, 2020
Sponsor
Sichuan Cancer Hospital and Research Institute
Collaborators
Wuhan University, Xiangya Hospital of Central South University, Shanxi Province Cancer Hospital, Shandong Tumor Hospital, Henan Cancer Hospital, Peking University Cancer Hospital & Institute, Hebei Medical University Fourth Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02399306
Brief Title
Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Cancer Hospital and Research Institute
Collaborators
Wuhan University, Xiangya Hospital of Central South University, Shanxi Province Cancer Hospital, Shandong Tumor Hospital, Henan Cancer Hospital, Peking University Cancer Hospital & Institute, Hebei Medical University Fourth Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, prospective, multicenter study.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma, Enteral Nutrition Therapy, Chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
chemoradiotherapy with Enteral Nutrition intervention
Arm Title
Arm B
Arm Type
Placebo Comparator
Arm Description
chemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
Enteral nutrition
Intervention Description
Patients in the Trial Group received concurrent chemoradiotherapy and standardized, whole-course enteral nutrition management.
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Weight Change from baseline to the end of treatment
Description
Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight.
Time Frame
up to 1 month after the treatment
Secondary Outcome Measure Information:
Title
Maximum Body Weight Change during treatment
Description
Maximum body weight change during treatment= the lowest body weight during treatment - baseline body weight.
Time Frame
up to 1 month after the treatment
Title
Blood biochemical examination
Description
albumin, haemoglobin,et al
Time Frame
up to 1 month after the treatment
Title
Grade 3-5 toxicity
Description
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
Time Frame
up to 1 month after the treatment
Title
Completion rate of chemoradiotherapy
Description
The proportion of people who complete all treatment as required
Time Frame
up to 1 month after the treatment
Title
short-term effect
Description
objective remission rate
Time Frame
up to 1 month after the treatment
Title
Overall Survival
Description
overall survival
Time Frame
at least 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TAO LI, MD, PhD
Organizational Affiliation
Sichuan Cancer Hospital and Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Sichuan Cancer Hospital & Institute
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35280748
Citation
Lyu J, Shi A, Li T, Li J, Zhao R, Zhu S, Wang J, Xing L, Yang D, Xie C, Shen L, Zhang H, Zhu G, Wang J, Pan W, Li F, Lang J, Shi H. Effects of Enteral Nutrition on Patients With Oesophageal Carcinoma Treated With Concurrent Chemoradiotherapy: A Prospective, Multicentre, Randomised, Controlled Study. Front Oncol. 2022 Feb 25;12:839516. doi: 10.3389/fonc.2022.839516. eCollection 2022.
Results Reference
derived

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

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