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OpenTrials
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NCT Number: NCT01472250

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

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.

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Key information

Conditions

Advanced Gastric Cancer

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lin Shen

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

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

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 2.
  • 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).

Treatment and study plan

Clinical chemo-drugs

Drug

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

Primary outcomes

  1. 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

  1. overall survival

    Time frame: 2 months

    OS 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

  2. quality of life

    Time frame: 6 weeks

    To evaluate the quality of life before and after chemotherapy of Chinese patients in real clinical practice

  3. treatment expense

    Time frame: 2 months

    To evaluate the treatment expense of first-line treatment of Chinese patients with advanced gastric cancer in real clinical practice

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 16, 2011
Registry last updated
May 9, 2017

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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