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

Advanced Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472250
• Other study ID #: CGOG1002
• Status: Completed
• Phase: N/A
• First received: October 28, 2011
• Last updated: May 7, 2017
• Start date: November 2011
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Lin Shen	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chemotherapy regimen	To evaluate the treatment model (singel or doublet or triplet chemotherapy)of patients with advanced gastric cancer in China	2 months
Secondary	overall survival	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 months
Secondary	quality of life	To evaluate the quality of life before and after chemotherapy of Chinese patients in real clinical practice	6 weeks
Secondary	treatment expense	To evaluate the treatment expense of first-line treatment of Chinese patients with advanced gastric cancer in real clinical practice	2 months