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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03286348
Other study ID # GINS-1001
Secondary ID
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
Health authority
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

Study Design


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
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