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NCT Number: NCT03485196

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Hospital Affiliated to Lanzhou University, Lanzhou, Gansu, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histopathology or cytopathology proven gastric cancer;
  • Operable advanced gastric cancer patients: primary lesions can be completely excision, no distant metastasis;
  • Postoperative patients who can tolerate 5-FU based (5-FU,S-1 or Capecitabine) adjuvant chemotherapy;
  • Life expectancy of at least 6 months;
  • ECOG(Eastern Cooperative Oncology Group ) score 0-1;
  • Age: 18~80 years old;
  • 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;
  • Roughly normal cardiopulmonary function: No coronary heart disease, myocardial infarction, pulmonary heart disease, refractory hypertension;
  • Not concomitant with other uncontrollable benign diseases before the recruitment;
  • Voluntarily signed the informed consent.

Exclusion criteria

  • Advanced gastric cancer patients with distant metastasis and inoperable ;
  • Patients who cannot tolerate 5-FU based adjuvant chemotherapy;
  • Pregnant or lactating women;
  • Patients who have no desire to participate in the study.

Treatment and study plan

Microsatellite instability

Other

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.

Primary outcomes

  1. Disease Free Survival

    Time frame: 5 years

    The time from the primary operation to disease recurrence or death.

Secondary outcomes

  1. Overall survival(OS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Qinghai University

Other

Collaborators

  • LanZhou University
  • Qinghai People's Hospital

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2018
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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