Analysis of Nutrition During Chemoradiotherapy in Patients With Gastrointestinal Cancer

NCT03286348 | Unknown DMC

• 1 other identifier: GINS-1001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Status; Gastrointestinal Cancer; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

gastric cancer patients and rectal cancer patients

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Hubei Cancer Hospital: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Ruijin Hospital: collaborator

Study Sites (1)

Zhen Zhang

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 18, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2021
• Last Updated: September 18, 2017

Record last verified: 2017-09

Locations

CN (1)