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

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

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Other: Microsatellite instability

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China
      • The Second Hospital Affiliated to Lanzhou University
  • Qinghai
    • Xining, Qinghai, China, 810000
      • Qinghai University Affiliated Hospital
    • Xining, Qinghai, China
      • People's Hospital of Qinghai Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

gastric cancer

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MSI-H group; We use the immunohistochemical expression of mismatch repair proteins (MutS protein homolog 2( MSH2),MutS protein homolog 6( MSH6) and PMS2（postmeiotic segregation increased 2 ）) to Determine the MSI status . When one antibodies or more show negative nuclear staining of the tumor cells, the MSI state can be defined as Microsatellite instability high (MSI-H).	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.
MSI-L group; We use the immunohistochemical expression of mismatch repair proteins (MLH1, MSH2, MSH6 and PMS2) to Determine the MSI status . when all the four antibodies show positive nuclear staining of the tumor cells, the MSI state can be defined as Microsatellite stable (MSI-L).	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.
MSS group; We use the immunohistochemical expression of mismatch repair proteins (MLH1, MSH2, MSH6 and PMS2) to Determine the MSI status . when all the four antibodies show positive nuclear staining of the tumor cells, the MSI state can be defined as Microsatellite stable (MSS).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survival	The time from the primary operation to disease recurrence or death.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Qinghai University
• Collaborators: LanZhou University; Qinghai People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: March 25, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 7, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Efficacy; Adjuvant chemotherapy; Fluorouracil; Operation; Microsatellite Instability
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Genomic Instability; Stomach Neoplasms; Microsatellite Instability
• Other Study ID Numbers: AHQU-2017003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No