NCT04408859

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

3.7 years

First QC Date

May 26, 2020

Last Update Submit

May 28, 2020

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Quality of life index

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

    2 years

Study Arms (2)

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

Neoadjuvant ChemotherapyDRUG

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

NACS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Central Study Contacts

Zaozao Wang

CONTACT

0086-10-88196851zaozao83630@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of GI surgery IV

Study Record Dates

First Submitted

May 26, 2020

First Posted

May 29, 2020

Study Start

April 17, 2018

Primary Completion

January 10, 2022

Study Completion

January 10, 2022

Last Updated

May 29, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)