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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 30, 2017
First Posted Date July 5, 2017
Last Update Posted Date November 17, 2017
Actual Study Start Date August 1, 2017
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 3, 2017)
  • 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
  • Morbidity [ Time Frame: 3 months after performing staging ]
    Complications of staging modalities
  • Quality of life [ Time Frame: Up to 5 years postoperative ]
    Quality of life with EORTC questionnaires
  • 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
  • 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
  • Mortality [ Time Frame: 3 months after performing staging ]
    90-day mortality of the staging modalities
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of PET and Laparoscopy in STagIng Advanced Gastric Cancer
Official Title Evaluation of PET and Laparoscopy in STagIng Advanced Gastric Cancer: a Multicenter Prospective Study
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

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
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.
Condition
  • Gastric Cancer
  • Staging
  • FDG-PET/CT
  • Diagnostic Laparoscopy
Intervention Not Provided
Study Groups/Cohorts 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 3, 2017)
543
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2025
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03208621
Other Study ID Numbers 16-1633/C
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jelle P. Ruurda, UMC Utrecht
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
Investigators Not Provided
PRS Account UMC Utrecht
Verification Date November 2017