Gastric CancerPLASTICNCT03208621
Evaluation of PET and Laparoscopy in STagIng Advanced Gastric Cancer
An observational study of Gastric Cancer and Staging, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer, Staging, FDG-PET/CT
- How many people
- 394 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2017to 1 Aug 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Siewert type I esophagogastric junction tumor
- Unfit or unwilling to undergo surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Conditions
- Gastric Cancer, Staging, FDG-PET/CT, Diagnostic Laparoscopy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after performing staging
Secondary outcomes (6)
Diagnostic performance
Sensitivity, specificity, positive predictive value and negative predictive value of FDG/PET-CT and Diagnostic Laparoscopy
Measured: 6 months after performing staging
Morbidity
Complications of staging modalities
Measured: 3 months after performing staging
Quality of life
Quality of life with EORTC questionnaires
Measured: Up to 5 years postoperative
Cost-reduction
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
Measured: 12 months after performing staging
Cost-effectiveness
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
Measured: 12 months after performing staging
Mortality
90-day mortality of the staging modalities
Measured: 3 months after performing staging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Aug 2017
- Primary completion1 Feb 2020
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 394 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Nederlandse Vereniging voor Heelkunde, Federatie Medisch Specialisten, Patientfederatie Nederland, Zorgverzekeraars Nederland
- Responsible party
- Principal investigator, Jelle P. Ruurda, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208621
- Sponsor's protocol ID
- 16-1633/C
- Acronym
- PLASTIC
- Status last verified
- Apr 2021
- First submitted
- 30 Jun 2017
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22549558de 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.
PubMed 38526832Brenkman 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.
PubMed 29678145
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PET and Laparoscopy in STagIng Advanced Gastric Cancer: a Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT03208621
- Acronym / sponsor ID
- PLASTIC / 16-1633/C
- Conditions
- Gastric Cancer, Staging, FDG-PET/CT, Diagnostic Laparoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 394 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Nederlandse Vereniging voor Heelkunde, Federatie Medisch Specialisten, Patientfederatie Nederland, Zorgverzekeraars Nederland
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Siewert type I esophagogastric junction tumor
- Unfit or unwilling to undergo surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
Diagnostic performance
Time frame: 6 months after performing staging
Morbidity
Time frame: 3 months after performing staging
Quality of life
Time frame: Up to 5 years postoperative
Cost-reduction
Time frame: 12 months after performing staging
Cost-effectiveness
Time frame: 12 months after performing staging
Mortality
Time frame: 3 months after performing staging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Background: PubMed 22549558Smyth 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.
- Derived from this study: PubMed 38526832de 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.
- Derived from this study: PubMed 29678145Brenkman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Staging, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in treatment strategy (time frame: 6 months after performing staging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03208621, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.