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

NCT ID: NCT01472250

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 498 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-07-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

chemotherapy

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

Clinical chemo-drugs

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

chief of department of GI oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lin Shen

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CGOG1002

Identifier Type: -

Identifier Source: org_study_id