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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-10-31

Brief Summary

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This is a randomized, prospective, multicenter study.

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Detailed Description

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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.

Conditions

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Esophageal Squamous Cell Carcinoma Enteral Nutrition Therapy Chemoradiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

chemoradiotherapy with Enteral Nutrition intervention

Group Type EXPERIMENTAL

Enteral nutrition

Intervention Type DRUG

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

radiotherapy

Intervention Type RADIATION

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.

Arm B

chemoradiotherapy

Group Type PLACEBO_COMPARATOR

radiotherapy

Intervention Type RADIATION

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.

Interventions

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Enteral nutrition

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

Intervention Type DRUG

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.

Intervention Type RADIATION

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No