Status:

COMPLETED

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

Lead Sponsor:

Affiliated Hospital of Qinghai University

Collaborating Sponsors:

Qinghai People's Hospital

LanZhou University

Conditions:

Gastric Cancer

Eligibility:

All Genders

18-80 years

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.

Eligibility Criteria

Inclusion

  • 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;
  • 9\. Voluntarily signed the informed consent.

Exclusion

  • 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.

Key Trial Info

Start Date :

March 1 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2021

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT03485196

Start Date

March 1 2017

End Date

April 1 2021

Last Update

August 10 2022

Active Locations (3)

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Page 1 of 1 (3 locations)

1

The Second Hospital Affiliated to Lanzhou University

Lanzhou, Gansu, China

2

Qinghai University Affiliated Hospital

Xining, Qinghai, China, 810000

3

People's Hospital of Qinghai Province

Xining, Qinghai, China

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