Evaluation of PET and Laparoscopy in STagIng Advanced Gastric Cancer (PLASTIC)

April 29, 2021 updated by: Jelle P. Ruurda, UMC Utrecht

Evaluation of PET and Laparoscopy in STagIng Advanced Gastric Cancer: a Multicenter Prospective Study

Objective: To evaluate the impact and cost-effectiveness of FDG-PET/CT (PET) and diagnostic laparoscopy (DLS) in addition to initial staging by CT and gastroscopy in patients with advanced gastric cancer.

Hypothesis: The study hypothesizes that performing DLS and PET for advanced gastric adenocarcinomas results in a reduction in the number of futile gastrectomies performed and a favorable cost-effectiveness. According to the literature, in 27% of patients a futile gastrectomy can be prevented, and the annual cost-reduction is an estimated €916.438.

Study design: The study design is a prospective observational study. Study population: The study population consists of patients with a surgically resectable, advanced gastric adenocarcinoma (cT3-4a,N0-3,M0), that are scheduled for treatment with curative intent after initial staging with gastroscopy and CT.

Usual care / comparison: Both PET and DLS were recently included in the new Dutch guidelines for the treatment of gastric cancer, as staging modalities for advanced (T3-4) tumors after initial staging. The costs of the study population will be compared to retrospective data of patients who underwent curative surgery (gastrectomy) after initial staging with CT alone.

Outcome measures: The primary outcome of this study will be the proportion of patients in whom the PET or DLS lead to a change in treatment strategy. The accuracy of each modality will be analyzed separately. Secondary outcome parameters will be diagnostic performance, morbidity and mortality, quality of life, cost-reduction and cost-effectiveness.

Sample size: Based on the expectation that 22% of patients will have a change in treatment strategy, at least 239 patients will be needed for this study to demonstrate that the diagnostic modalities in the new guideline are break-even. Approximately 543 patients will be eligible for the study in 36 months.

Cost-effectiveness analysis: A state-of-the-art cost-effectiveness analysis and budget impact analysis will be performed on the additive value of PET and DLS by both prospective and retrospective data collection

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

394

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients with a surgically resectable, advanced gastric adenocarcinoma (cT3-4a,N0-3,M0), that are scheduled for treatment with curative intent after initial staging with gastroscopy and CT.

Description

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the stomach or esophagogastric junction (Siewert II and III), by gastroscopy.
  • Underwent evaluation with computed tomography (CT) of the abdomen and chest.
  • Surgically resectable, advanced tumor (cT3-4a,N0-3,M0), as determined by a multidisciplinary team meeting. An advanced tumor is defined as a transmural tumor with an irregular outer margin, objectified on CT.
  • Intention to perform a curative gastrectomy

Exclusion Criteria:

  • Siewert type I esophagogastric junction tumor
  • Unfit or unwilling to undergo surgery

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
Observational group
The diagnostic tests to be investigated in this study is the use of PET and DLS in addition to the initial staging with gastroscopy and CT of patients with an advanced tumor (cT3-4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in treatment strategy
Time Frame: 6 months after performing staging
The primary outcome of this study will be the proportion of patients in whom the PET or DLS lead to a change in treatment strategy.
6 months after performing staging

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance
Time Frame: 6 months after performing staging
Sensitivity, specificity, positive predictive value and negative predictive value of FDG/PET-CT and Diagnostic Laparoscopy
6 months after performing staging
Morbidity
Time Frame: 3 months after performing staging
Complications of staging modalities
3 months after performing staging
Quality of life
Time Frame: Up to 5 years postoperative
Quality of life with EORTC questionnaires
Up to 5 years postoperative
Cost-reduction
Time Frame: 12 months after performing staging
Annual reduction in costs in the Netherlands of FDG-PET/CT and diagnostic laparoscopy, measured by reviewing hospital financial files and comparing with the previous situation without the staging
12 months after performing staging
Cost-effectiveness
Time Frame: 12 months after performing staging
Cost-effectiveness of FDG-PET/CT and diagnostic laparoscopy, measured by reviewing hospital financial files and comparing with the previous situation without the staging modalities
12 months after performing staging
Mortality
Time Frame: 3 months after performing staging
90-day mortality of the staging modalities
3 months after performing staging

Collaborators and Investigators

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

Sponsor

UMC Utrecht

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development
Nederlandse Vereniging voor Heelkunde
Federatie Medisch Specialisten
Patientfederatie Nederland
Zorgverzekeraars Nederland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2017

Primary Completion (Actual)

February 1, 2020

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 5, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-1633/C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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