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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University
ClinicalTrials.gov Identifier:
NCT01472250
First received: October 28, 2011
Last updated: September 3, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Advanced Gastric Cancer
Drug: Clinical chemo-drugs

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • chemotherapy regimen [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    To evaluate the treatment model (singel or doublet or triplet chemotherapy)of patients with advanced gastric cancer in China


Secondary Outcome Measures:
  • overall survival [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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

  • quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To evaluate the quality of life before and after chemotherapy of Chinese patients in real clinical practice

  • treatment expense [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    To evaluate the treatment expense of first-line treatment of Chinese patients with advanced gastric cancer in real clinical practice


Biospecimen Retention:   Samples With DNA

the tumor tissue samples were collected to do gene mutation analysis


Estimated Enrollment: 500
Study Start Date: November 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
chemotherapy
Eligible patients will accept generalized chemotherapy according to the investigator's assessment.
Drug: Clinical 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


  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with advanced gastric cancer

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472250

Contacts
Contact: lin shen, MD 861088196561 lin100@medmail.com.cn
Contact: jifang gong, MD 861088196088 gongjifang@gmail.com

Locations
China, Beijing
Lin Shen Recruiting
Beijing, Beijing, China, 100142
Contact: lin shen, MD    861088196561    lin100@medmail.com.cn   
Contact: jifang gong, MD    861088196088    gongjifang@gmail.com   
Principal Investigator: lin shen, MD         
Sponsors and Collaborators
Peking University
  More Information

No publications provided

Responsible Party: Shen Lin, chief of department of GI oncology, Peking University
ClinicalTrials.gov Identifier: NCT01472250     History of Changes
Other Study ID Numbers: CGOG1002
Study First Received: October 28, 2011
Last Updated: September 3, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University:
Advanced Gastric Cancer
chemotherapy
quality of life
treatment expense
patients accepted first-line chemotherapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on October 01, 2014