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Trial record 1 of 1 for:    NCT 02399306
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Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02399306
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : March 17, 2020
Sponsor:
Collaborators:
Wuhan University
Xiangya Hospital of Central South University
Shanxi Province Cancer Hospital
Shandong Tumor Hospital
Henan Cancer Hospital
Beijing Cancer Hospital
Hebei Medical University Fourth Hospital
Information provided by (Responsible Party):
LI TAO, Sichuan Cancer Hospital and Research Institute

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

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Enteral Nutrition Therapy Chemoradiotherapy Drug: Enteral nutrition Radiation: radiotherapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Arm A
chemoradiotherapy with Enteral Nutrition 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.


Placebo Comparator: Arm B
chemoradiotherapy
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.





Primary Outcome Measures :
  1. Body Weight Change from baseline to the end of treatment [ Time Frame: up to 1 month after the treatment ]
    Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight.


Secondary Outcome Measures :
  1. Maximum Body Weight Change during treatment [ Time Frame: up to 1 month after the treatment ]
    Maximum body weight change during treatment= the lowest body weight during treatment - baseline body weight.

  2. Blood biochemical examination [ Time Frame: up to 1 month after the treatment ]
    albumin, haemoglobin,et al

  3. Grade 3-5 toxicity [ Time Frame: up to 1 month after the treatment ]
    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

  4. Completion rate of chemoradiotherapy [ Time Frame: up to 1 month after the treatment ]
    The proportion of people who complete all treatment as required

  5. short-term effect [ Time Frame: up to 1 month after the treatment ]
    objective remission rate

  6. Overall Survival [ Time Frame: at least 2 years ]
    overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399306


Locations
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China, Sichuan
Sichuan Cancer Hospital & Institute
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
Sichuan Cancer Hospital and Research Institute
Wuhan University
Xiangya Hospital of Central South University
Shanxi Province Cancer Hospital
Shandong Tumor Hospital
Henan Cancer Hospital
Beijing Cancer Hospital
Hebei Medical University Fourth Hospital
Investigators
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Study Chair: TAO LI, MD, PhD Sichuan Cancer Hospital and Research Institute

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Responsible Party: LI TAO, Section Head, Sichuan Cancer Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT02399306    
Other Study ID Numbers: scch2015001
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases