Quality of Life in Advanced Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

• Conditions: QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant Chemotherapy
• Interventions: Drug: Neoadjuvant Chemotherapy

• Registration Number: NCT04408859
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-04-17
• Status Verified: 2020-05
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-28
• Last Update Submitted: 2020-05-28
• Study First Posted: 2020-05-29
• Last Update Posted: 2020-05-29
• Primary Completion: 2022-01-10
• Study Completion: 2022-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 290

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NACS	Neoadjuvant Chemotherapy	The patients with advanced gastric cancer who received neoadjuvant chemotherapy followed by surgery（NACS）.

Primary Outcome Measures

Name	Time	Method
Quality of life index	2 years	The change of quality of life index during the 2 years after surgery.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China