Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma
Study Details
Study Description
Brief Summary
This is a randomized, prospective, multicenter study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Body Weight Change from baseline to the end of treatment [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
- Maximum Body Weight Change during treatment [up to 1 month after the treatment]
Maximum body weight change during treatment= the lowest body weight during treatment - baseline body weight.
- Blood biochemical examination [up to 1 month after the treatment]
albumin, haemoglobin,et al
- Grade 3-5 toxicity [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
- Completion rate of chemoradiotherapy [up to 1 month after the treatment]
The proportion of people who complete all treatment as required
- short-term effect [up to 1 month after the treatment]
objective remission rate
- Overall Survival [at least 2 years]
overall survival
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 to 75 years old
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male or femalePathologically or cytologically proven esophageal squamous cell carcinoma
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Clinical stage II or stage III
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PG-SGA≧2
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Karnofsky performance score(KPS) ≧70
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Estimated life expectancy of at least 12 weeks
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Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³
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Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal
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Creatinine normal OR creatinine clearance ≥ 60 mL/min
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Patients have good compliance to treatment and follow-up of acceptance
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Forced expiratory volume in one second（FEV1） ≥ 1.5 litre or ≥ 75% of the reference value
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the functions of the heart, kidney, liver were basically normal, with no chemotherapy and radiotherapy contraindications
Exclusion Criteria:
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Patients with severely bowel function impaired or can not tolerate enteral nutrition
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Patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted
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Patients have no risk of malnutrition
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Patients have severe malnutrition (weight loss >10% or <30 g/L, BMI<18.5 kg/m2 or hemoglobin<90 g/L before the treatment
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Patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction
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Patients can not tolerate chemotherapy and radiotherapy
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Patients who have distant metastasis
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The primary tumor or lymph node already received surgical treatment (except for biopsy);
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Patient who received radiotherapy for primary tumor or lymph node;
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Patient who received chemotherapy or immunotherapy;
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Patient who suffered from other malignant tumor;
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Patient who have taken other drug test within 1 month;
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Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
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Subject with a severe allergic history or idiosyncratic;
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Subject with severe pulmonary and cardiopathic disease history;
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Refuse or incapable to sign the informed consent form of participating this trial;
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Drug abuse or alcohol addicted;
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Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
- Peking University Cancer Hospital & Institute
- Hebei Medical University Fourth Hospital
Investigators
- Study Chair: TAO LI, MD, PhD, Sichuan Cancer Hospital and Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- scch2015001