NCT03208621

Brief Summary

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

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
394

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 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

First Submitted

Initial submission to the registry

June 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

2.5 years

First QC Date

June 30, 2017

Last Update Submit

April 29, 2021

Conditions

Gastric CancerStagingFDG-PET/CTDiagnostic Laparoscopy

Outcome Measures

Primary Outcomes (1)

  • Change in treatment strategy

    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 Outcomes (6)

  • Diagnostic performance

    6 months after performing staging

  • Morbidity

    3 months after performing staging

  • Quality of life

    Up to 5 years postoperative

  • Cost-reduction

    12 months after performing staging

  • Cost-effectiveness

    12 months after performing staging

  • +1 more secondary outcomes

Study Arms (1)

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)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (3)

  • Smyth E, Schoder H, Strong VE, Capanu M, Kelsen DP, Coit DG, Shah MA. A prospective evaluation of the utility of 2-deoxy-2-[(18) F]fluoro-D-glucose positron emission tomography and computed tomography in staging locally advanced gastric cancer. Cancer. 2012 Nov 15;118(22):5481-8. doi: 10.1002/cncr.27550. Epub 2012 May 1.

    PMID: 22549558BACKGROUND

  • de Jongh C, van der Meulen MP, Gertsen EC, Brenkman HJF, van Sandick JW, van Berge Henegouwen MI, Gisbertz SS, Luyer MDP, Nieuwenhuijzen GAP, van Lanschot JJB, Lagarde SM, Wijnhoven BPL, de Steur WO, Hartgrink HH, Stoot JHMB, Hulsewe KWE, Spillenaar Bilgen EJ, van Det MJ, Kouwenhoven EA, Daams F, van der Peet DL, van Grieken NCT, Heisterkamp J, van Etten B, van den Berg JW, Pierie JP, Eker HH, Thijssen AY, Belt EJT, van Duijvendijk P, Wassenaar E, Wevers KP, Hol L, Wessels FJ, Haj Mohammad N, Frederix GWJ, van Hillegersberg R, Siersema PD, Vegt E, Ruurda JP; PLASTIC Study Group. Impact of 18FFDG-PET/CT and Laparoscopy in Staging of Locally Advanced Gastric Cancer: A Cost Analysis in the Prospective Multicenter PLASTIC-Study. Ann Surg Oncol. 2024 Jun;31(6):4005-4017. doi: 10.1245/s10434-024-15103-4. Epub 2024 Mar 25.

    PMID: 38526832DERIVED

  • Brenkman HJF, Gertsen EC, Vegt E, van Hillegersberg R, van Berge Henegouwen MI, Gisbertz SS, Luyer MDP, Nieuwenhuijzen GAP, van Lanschot JJB, Lagarde SM, de Steur WO, Hartgrink HH, Stoot JHMB, Hulsewe KWE, Spillenaar Bilgen EJ, van Det MJ, Kouwenhoven EA, van der Peet DL, Daams F, van Sandick JW, van Grieken NCT, Heisterkamp J, van Etten B, Haveman JW, Pierie JP, Jonker F, Thijssen AY, Belt EJT, van Duijvendijk P, Wassenaar E, van Laarhoven HWM, Wessels FJ, Haj Mohammad N, van Stel HF, Frederix GWJ, Siersema PD, Ruurda JP; PLASTIC Study Group. Evaluation of PET and laparoscopy in STagIng advanced gastric cancer: a multicenter prospective study (PLASTIC-study). BMC Cancer. 2018 Apr 20;18(1):450. doi: 10.1186/s12885-018-4367-9.

    PMID: 29678145DERIVED

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
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 5, 2017

Study Start

August 1, 2017

Primary Completion

February 1, 2020

Study Completion

August 1, 2025

Last Updated

May 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)