Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer

Gastrointestinal Cancer Clinical Trial

Official title:

Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03286348
• Other study ID #: GINS-1001
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2017
• Last updated: September 15, 2017
• Start date: September 1, 2017
• Est. completion date: October 1, 2021

Study information

• Verified date: September 2017
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemoradiotherapy
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Nutritional Status

Locations

Country	Name	City	State
China	Zhen Zhang	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Fudan University	First Affiliated Hospital of Chongqing Medical University, Hubei Cancer Hospital, Ruijin Hospital, The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall Survival		From date of randomization until the date of death from any cause, assessed up to 3 years