An observational study in Nutritional Status, Gastrointestinal Cancer and Chemoradiotherapy, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-09-18.
Sponsored by Fudan University · Observational
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.
gastric cancer patients and rectal cancer patients
Inclusion Criteria for Gastric Cancer:
Inclusion Criteria for Rectal Cancer:
Exclusion Criteria:
Local Control rate
Number of participants with abdominal or pelvic failure after surgery, evaluated using Kaplan-Meier Curve
Time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 3 years
Disease-free Survival
Time frame: 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
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 years
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Fudan University