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

NCT02399306 | Completed Phase 3

• 1 other identifier: scch2015001
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, prospective, multicenter study.

Conditions

Esophageal Squamous Cell Carcinoma; Enteral Nutrition Therapy; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Maximum Body Weight Change during treatment

  up to 1 month after the treatment

• Blood biochemical examination

  up to 1 month after the treatment

• Grade 3-5 toxicity

  up to 1 month after the treatment

• Completion rate of chemoradiotherapy

  up to 1 month after the treatment

• short-term effect

  up to 1 month after the treatment

Study Arms (2)

Arm A

EXPERIMENTAL

chemoradiotherapy with Enteral Nutrition intervention

Drug: Enteral nutrition; Radiation: radiotherapy

Arm B

PLACEBO COMPARATOR

chemoradiotherapy

Radiation: radiotherapy

Interventions

Enteral nutrition DRUG

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

Arm A

radiotherapy 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 A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead
• Wuhan University: collaborator
• Xiangya Hospital of Central South University: collaborator
• Shanxi Province Cancer Hospital: collaborator
• Shandong Tumor Hospital: collaborator
• Henan Cancer Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Hebei Medical University Fourth Hospital: collaborator

Study Sites (1)

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• 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.

  PMID: 35280748 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Enteral Nutrition; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, 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

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• TAO LI, MD, PhD

  Sichuan Cancer Hospital and Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 26, 2015
• Study Start: September 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

CN (1)