Skip to main content
Clinical Trials/NCT01472250
NCT01472250
Completed
N/A

A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China

Peking University1 site in 1 country498 target enrollmentNovember 2011

Overview

Phase
N/A
Intervention
Clinical chemo-drugs
Conditions
Advanced Gastric Cancer
Sponsor
Peking University
Enrollment
498
Locations
1
Primary Endpoint
chemotherapy regimen
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This is a multi-center, prospective and observational clinical study. Eligible patients will accept generalized chemotherapy according to the investigator's assessment. Information related to the treatment, including medication, disease condition, expenses, etc. will be periodically collected. Follow-up at 2-month intervals will be periodically performed to continually collect information about the disease progression, subsequent treatment and survival until death or completion of the study.

Recruited patients will fill out questionnaires about quality of life before initiation of treatment, at Cycle 3 and completion of first-line treatment.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
July 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Peking University
Responsible Party
Principal Investigator
Principal Investigator

Shen Lin

chief of department of GI oncology

Peking University

Eligibility Criteria

Inclusion Criteria

  • The patient has histologically confirmed locally-advanced or recurrent and/or metastatic gastric or esophagogastric junction adenocarcinoma, has missed the opportunity of surgical excision, making curative therapy impossible.
  • The informed consent form is signed.
  • A specimen of tumor tissue (puncture biopsy or surgical specimen) is available.
  • ECOG performance status is 0, 1 or
  • The patient's general conditions and functions of important organs allow generalized chemotherapy according to the investigator's judgment
  • The patient is aged≥18

Exclusion Criteria

  • The patient is known to be allergic to any study drug.
  • The patient is recruited in other clinical study or is planned to participate into other clinical study.
  • The patient has previously accepted chemotherapy against advanced or metastatic diseases (the patient may be recruited if the previous adjuvant therapy/neoadjuvant therapy was completed more than 6 months before inclusion).

Arms & Interventions

chemotherapy

Eligible patients will accept generalized chemotherapy according to the investigator's assessment.

Intervention: Clinical chemo-drugs

Outcomes

Primary Outcomes

chemotherapy regimen

Time Frame: 2 months

To evaluate the treatment model (singel or doublet or triplet chemotherapy)of patients with advanced gastric cancer in China

Secondary Outcomes

  • overall survival(2 months)
  • quality of life(6 weeks)
  • treatment expense(2 months)

Study Sites (1)

Loading locations...

Similar Trials