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

NCT01472250 | Completed

• 1 other identifier: CGOG1002
• Study Type: observational
• Target: 498
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• chemotherapy regimen

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

  2 months

Secondary Outcomes (3)

• overall survival

  2 months

• quality of life

  6 weeks

• treatment expense

  2 months

Study Arms (1)

chemotherapy

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

Drug: Clinical chemo-drugs

Interventions

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

chemotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with advanced gastric cancer

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Lin Shen

Beijing, Beijing Municipality, 100142, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

the tumor tissue samples were collected to do gene mutation analysis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of department of GI oncology

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 16, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

CN (1)