NCT04989764

Brief Summary

  • Patients with gastric adenocarcinoma
  • Comparison: perioperative chemotherapy vs. adjuvant therapy.
  • Sample size differences between the two groups.
  • Kaplan meier survival analysis, overall survival and disease free survival

Trial Health

100
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

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

January 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
Last Updated

August 4, 2021

Status Verified

July 1, 2021

Enrollment Period

4.9 years

First QC Date

July 27, 2021

Last Update Submit

August 3, 2021

Conditions

Gastric Cancer, Outcomes, Pakistan, Adjuvant Chemotherapy, Perioperative Chemotherapy

Outcome Measures

Primary Outcomes (2)

  • The overall survival

    The overall survival (OS) was defined as the length of the time from date of diagnosis till last follow-up or death

    from January 2015 till December 2019

  • The disease-free survival

    The disease free survival (DFS) as the length of the time from date of last treatment which is either perioperative or adjuvant chemotherapy to tumor relapse or death.

    from January 2015 till December 2019

Study Arms (2)

perioperative chemotherapy vs. adjuvant therapy in gastric ca patients

perioperative chemotherapy group vs. adjuvant chemotherapy group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cancer patients who had histologically proven gastric adenocarcinoma diagnosed at Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH \& RC), between January 2015 and December 2019

You may qualify if:

  • We included histologically proven gastric adenocarcinoma patient with operable disease and the patients who completed their prescribed perioperative or adjuvant chemotherapy cycles

You may not qualify if:

  • Patients were excluded if they had Tis or T1, N0 disease, inoperable disease, metastatic. In addition, all those who did not undergo adequate lymphadenectomy (\< D2) or had R1 margins following surgery were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 4, 2021

Study Start

January 1, 2015

Primary Completion

December 1, 2019

Study Completion

February 1, 2021

Last Updated

August 4, 2021

Record last verified: 2021-07