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

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, prospective, multicenter study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan Cancer Hospital and Research Institute
• Collaborators: 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
• Treatments: Cisplatin; Docetaxel

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;