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

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ClinicalTrials.gov Identifier: NCT03208621
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Nederlandse Vereniging voor Heelkunde
Federatie Medisch Specialisten
Patientfederatie Nederland
Zorgverzekeraars Nederland
Information provided by (Responsible Party):
Jelle P. Ruurda, UMC Utrecht

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


Condition or disease
Gastric Cancer Staging FDG-PET/CT Diagnostic Laparoscopy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 543 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Evaluation of PET and Laparoscopy in STagIng Advanced Gastric Cancer: a Multicenter Prospective Study
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Morbidity [ Time Frame: 3 months after performing staging ]
    Complications of staging modalities

  3. Quality of life [ Time Frame: Up to 5 years postoperative ]
    Quality of life with EORTC questionnaires

  4. Cost-reduction [ Time Frame: 6 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

  5. Cost-effectiveness [ Time Frame: 6 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

  6. Mortality [ Time Frame: 3 months after performing staging ]
    90-day mortality of the staging modalities



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208621


Locations
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Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Jelle Ruurda, MD PhD    +31 (0)88-755 8074    j.p.ruurda@umcutrecht.nl   
Contact: Hylke Brenkman, MD    +31 (0)88-755 8074    h.j.f.brenkman@umcutrecht.nl   
Principal Investigator: Jelle P Ruurda, MD PhD         
Sub-Investigator: Hylke JF Brenkman, MD         
Sub-Investigator: Richard van Hillegersberg, MD PhD         
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Nederlandse Vereniging voor Heelkunde
Federatie Medisch Specialisten
Patientfederatie Nederland
Zorgverzekeraars Nederland
Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jelle P. Ruurda, Doctor, UMC Utrecht
ClinicalTrials.gov Identifier: NCT03208621    
Other Study ID Numbers: 16-1633/C
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases