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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03485196

Enrollment

1000

Registered

2018-04-02

Start date

2017-03-01

Completion date

2021-04-01

Last updated

2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Microsatellite Instability, Fluorouracil, Adjuvant chemotherapy, Efficacy, Operation

Brief summary

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

Detailed description

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

Interventions

OTHERMicrosatellite 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Overall survival(OS)	5 years	The The time from operation to death or the last follow-up. The time from operation to death or the last follow-up.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026