COMPARATIVE EFFECTS OF PERIOPERATIVE AND ADJUVANT CHEMOTHERAPY ON OUTCOMES OF OPERABLE GASTRIC CANCER: EXPERIENCE FROM A CANCER CARE CENTER

August 3, 2021 updated by: Shaukat Khanum Memorial Cancer Hospital & Research Centre
  • 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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
perioperative chemotherapy vs. adjuvant therapy in gastric ca patients
perioperative chemotherapy group vs. adjuvant chemotherapy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The overall survival
Time Frame: from January 2015 till December 2019
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
Time Frame: from January 2015 till December 2019
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-05-03-20-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer, Outcomes, Pakistan, Adjuvant Chemotherapy, Perioperative Chemotherapy

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