Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01472250
Enrollment
498
Registered
2011-11-16
Start date
2011-11-30
Completion date
2016-07-31
Last updated
2017-05-09

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

Conditions

Advanced Gastric Cancer

Keywords

Advanced Gastric Cancer, chemotherapy, quality of life, treatment expense, patients accepted first-line chemotherapy

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.

Interventions

DRUGClinical chemo-drugs

Clinical drugs will be selected by the investigator according to recommendations in Chinese and foreign guidelines and depending on clinical experience and the patient's individual conditions, including but not limited to the drugs listed below: Platinum products: oxaliplatin, cisplatin Fluorouracil products: 5-fluorouracil, capecitabine, TS-1 Taxanes: paclitaxel, docetaxel

Sponsors

Peking University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. 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. 2. The informed consent form is signed. 3. A specimen of tumor tissue (puncture biopsy or surgical specimen) is available. 4. ECOG performance status is 0, 1 or 2. 5. The patient's general conditions and functions of important organs allow generalized chemotherapy according to the investigator's judgment 6. The patient is aged≥18

Exclusion criteria

1. The patient is known to be allergic to any study drug. 2. The patient is recruited in other clinical study or is planned to participate into other clinical study. 3. 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).

Design outcomes

Primary

MeasureTime frameDescription
chemotherapy regimen2 monthsTo evaluate the treatment model (singel or doublet or triplet chemotherapy)of patients with advanced gastric cancer in China

Secondary

MeasureTime frameDescription
overall survival2 monthsOS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 2 months till death or lost
quality of life6 weeksTo evaluate the quality of life before and after chemotherapy of Chinese patients in real clinical practice
treatment expense2 monthsTo evaluate the treatment expense of first-line treatment of Chinese patients with advanced gastric cancer in real clinical practice

Countries

China

Outcome results

None listed

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