Quality of Life in Advanced Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant Chemotherapy Clinical Trial

Official title:

Quality of Life in Patient With Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04408859
• Other study ID #: QOL-201804
• Status: Recruiting
• Start date: April 17, 2018
• Est. completion date: January 10, 2022

Study information

• Verified date: May 2020
• Source: Beijing Cancer Hospital
• Contact: Zaozao Wang
• Phone: 0086-10-88196851
• Email: zaozao83630[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to explore the influence of neoadjuvant chemotherapy in the long term quality of life with advanced gastric cancer patients.

Description:

Preoperative adjuvant chemotherapy combined with postoperative adjuvant therapy mode was included in the 2018 version of the National Comprehensive Cancer Network (NCCN) guideline as an optional treatment (category 2B) for prospective resectable advanced gastric cancer cases (≥cT2, any N).At home and abroad, the research on neoadjuvant chemotherapy for advanced gastric cancer mainly focuses on the safety and long-term survival, and there are few studies on the quality of life. This study, according to EORTC QLQ-C30 and QLQ-STO22 assessment scale, explores the long term effect of neoadjuvant chemotherapy on the quality of life in patients with advanced gastric cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients age older than 18 years (including 18 years old);

• Diagnosis of adenocarcinoma of the stomach

• The clinic stage is =T2 and any N stage

• Patient had curative surgical resection, including proximal, distal, or total gastrectomy

Exclusion Criteria:

• Psychiatric or psychological abnormality precluding informed consent or ability to complete questionnaires

• Non-psychiatric disorder causing a lack of capacity to give consent or an inability to complete questionnaires (ie dementia, stroke)

• Early gastric cancer.

Related Conditions & MeSH terms

• QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant Chemotherapy
• Stomach Neoplasms

Intervention

Drug:
• Neoadjuvant Chemotherapy
The patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life index	The change of quality of life index during the 2 years after surgery.	2 years