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Quality of Life in Advanced Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

NCT ID: NCT04408859

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-17

Study Completion Date

2022-01-10

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NACS

The patients with advanced gastric cancer who received neoadjuvant chemotherapy followed by surgery（NACS）.

Neoadjuvant Chemotherapy

Intervention Type DRUG

The patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery.

SA

The patients with advanced gastric cancer who received surgery alone.

No interventions assigned to this group

Interventions

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Neoadjuvant Chemotherapy

The patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Xiangqian Su

Chief of GI surgery IV

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zaozao Wang

Role: CONTACT

Phone: 0086-10-88196851

Email: [email protected]

Facility Contacts

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Zaozao Wang

Role: primary

Jianhong Yu

Role: backup

Other Identifiers

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QOL-201804

Identifier Type: -

Identifier Source: org_study_id