Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer

• Conditions: Chemoradiotherapy; Nutritional Status; Gastrointestinal Cancer

• Registration Number: NCT03286348
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2017-09
• Study Start: 2017-09-01
• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-15
• Last Update Submitted: 2017-09-15
• Study First Posted: 2017-09-18
• Last Update Posted: 2017-09-18
• Primary Completion: 2018-09-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhen Zhang; 🇨🇳 Shanghai, Shanghai, China