Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer

Study Overview
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Brief Summary
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To assess the effectiveness of close and intense monitoring on nutritional status of gastrointestinal cancer patients during chemoradiotherapy (CRT), 500 CRT patients diagnosed with gastrointestinal system are going to be recruited into this prospective study. Patient-generated subjective global assessment (PG-SGA) scale and nutrition risk screening (NRS-2002) are used for nutritional assessment at the beginning and the end of CRT; Beside the nutritional parameters, Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and gastric cancer module (QLQ-STO22) are used to measure quality of life in patients with gastric cancer while EORTC QLQ-C30 and Colorectal Cancer-Specific Quality of Life Questionnaire (QLQ-CR38) give assessment in colorectal cancer. The acute and late radiation toxicities were evaluated based on Conmon terminology criteria (CTC V3.0) and the toxicity criteria of RTOG/EORTC, respectively. Follow-ups every 3-6 months until three years after chemoradiotherapy are involved. Response Evaluation Criteria in Solid Tumors (RECIST) guidelines are used for response assessment. The primary endpoints are 3-year local control, disease-free survival, distant metastasis and overall survival rate.

Official Title
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Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer

Conditions
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Nutritional Status, Gastrointestinal Cancer, Chemoradiotherapy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Gastric Cancer: pathological confirmed adenocarcinoma clinical stage T3-4 and/or N+ after radical surgery without distance metastases KPS >=70 without previous radiotherapy sign the inform consent Inclusion Criteria for Rectal Cancer: pathological confirmed adenocarcinoma clinical stage T3-4 and/or N+ the distance from anal verge less than 12 cm without distance metastases KPS >=70 without previous anti-cancer therapy sign the inform consent Exclusion Criteria: pregnancy or breast-feeding women serious medical illness baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN DPD deficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Control rate | Number of participants with abdominal or pelvic failure after surgery, evaluated using Kaplan-Meier Curve | From date of randomization until the date of first documented pelvic failure, assessed up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years | 
| Overall Survival |  | From date of randomization until the date of death from any cause, assessed up to 3 years |