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Status unknownNCT04408859Updated May 29, 2020

Quality of Life in Advanced Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

An observational study in QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant Chemotherapy, sponsored by Peking University Cancer Hospital & Institute. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-29.

Sponsored by Peking University Cancer Hospital & Institute · Observational

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
290
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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

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In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 290 is close to the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

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Lead sponsor

Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have had curative resection at Beijing Cancer Hospital for advanced gastric cancer and finish the questionnaire.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
290 participants (estimated)
Patient registry
No

Groups and cohorts

  • NACS

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

    Drug: Neoadjuvant Chemotherapy

  • SA

    The patients with advanced gastric cancer who received surgery alone.

Interventions

  • DrugNeoadjuvant Chemotherapy

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

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What researchers measure

Primary outcomes

  1. Quality of life index

    The change of quality of life index during the 2 years after surgery.

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04408859
Lead sponsor
Peking University Cancer Hospital & Institute
Responsible party
Xiangqian Su (Chief of GI surgery IV, Peking University Cancer Hospital & Institute) — Principal investigator
First posted
May 29, 2020
Start date
Apr 17, 2018
Primary completion
Jan 10, 2022 (estimated)
Completion
Jan 10, 2022 (estimated)
Last update
May 29, 2020

Study contacts

Zaozao Wang
Contact
zaozao83630@sina.com
0086-10-88196851

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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