The Relationship Between Microsatellite Instability and Efficacy of Fluorouracil Based Adjuvant Chemotherapy in Gastric Cancer After Operation

Gastric Cancer Clinical Trial

Official title:

The Relationship Between Microsatellite Instability and Efficacy of Fluorouracil Based Adjuvant Chemotherapy in Gastric Cancer After Operation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03485196
• Other study ID #: AHQU-2017003
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: April 1, 2021

Study information

• Verified date: August 2022
• Source: Affiliated Hospital of Qinghai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.

Description:

To explore the relationship between Microsatellite instability and efficacy of fluorouracil based adjuvant chemotherapy in gastric cancer after operation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Histopathology or cytopathology proven gastric cancer;

2. Operable advanced gastric cancer patients: primary lesions can be completely excision, no distant metastasis;

3. Postoperative patients who can tolerate 5-FU based (5-FU,S-1 or Capecitabine) adjuvant chemotherapy;

4. Life expectancy of at least 6 months;

5. ECOG(Eastern Cooperative Oncology Group ) score 0-1;

6. Age: 18~80 years old;

7. Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function).

• For example: WBC(White blood cell count )>4.0×109/L; NEU(Neutrophils)>1.5×109/L; PLT(Platelet)>100×109/L;

8. Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;

9. Not concomitant with other uncontrollable benign diseases before the recruitment;

9. Voluntarily signed the informed consent.

Exclusion Criteria:

1. Advanced gastric cancer patients with distant metastasis and inoperable ;

2. Patients who cannot tolerate 5-FU based adjuvant chemotherapy;

3. Pregnant or lactating women;

4. Patients who have no desire to participate in the study.

Related Conditions & MeSH terms

• Gastric Cancer
• Microsatellite Instability
• Stomach Neoplasms

Intervention

Other:
• Microsatellite instability
The microsatellite instability status are definite to three type:MSI-H, MSI-L,and MSS. The gastric cancer patients who received D2 resection were included in 3 groups:MSI-H group, MSI-L group,and MSS group. All patient must be accept fluorouracil(5-FU) based adjuvant chemotherapy. We will analyze the relationship between MSI status and efficacy of 5-FU based adjuvant chemotherapy by observing the survival period of patients with different MSI status.

Locations

Country	Name	City	State
China	The Second Hospital Affiliated to Lanzhou University	Lanzhou	Gansu
China	People's Hospital of Qinghai Province	Xining	Qinghai
China	Qinghai University Affiliated Hospital	Xining	Qinghai

Sponsors (3)

Lead Sponsor	Collaborator
Affiliated Hospital of Qinghai University	LanZhou University, Qinghai People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival	The time from the primary operation to disease recurrence or death.	5 years
Secondary	Overall survival(OS)	The The time from operation to death or the last follow-up. The time from operation to death or the last follow-up.	5 years