Clinical trial NCT03286348: Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer
Official title: Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutritional Status
Gastrointestinal Cancer
Chemoradiotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: Hubei Cancer Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: Ruijin Hospital
First posted: 2017-09-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: gastric cancer patients and rectal cancer patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Local Control rate
timeFrame: From date of randomization until the date of first documented pelvic failure, assessed up to 3 years
Secondary outcomes:
measure: Disease-free Survival
timeFrame: 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
measure: Overall Survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhen Zhang
state: Shanghai
Study officials:
References: