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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02399306
Other study ID # scch2015001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2014
Est. completion date October 2017

Study information

Verified date March 2020
Source Sichuan Cancer Hospital and Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, prospective, multicenter study.


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.


Recruitment information / eligibility

Status Completed
Enrollment 222
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
China Sichuan Cancer Hospital & Institute Chengdu Sichuan

Sponsors (8)

Lead Sponsor Collaborator
Sichuan Cancer Hospital and Research Institute 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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Maximum Body Weight Change during treatment Maximum body weight change during treatment= the lowest body weight during treatment - baseline body weight. up to 1 month after the treatment
Secondary Blood biochemical examination albumin, haemoglobin,et al up to 1 month after the treatment
Secondary 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 up to 1 month after the treatment
Secondary Completion rate of chemoradiotherapy The proportion of people who complete all treatment as required up to 1 month after the treatment
Secondary short-term effect objective remission rate up to 1 month after the treatment
Secondary Overall Survival overall survival at least 2 years
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