Gastric CancerNCT04878783
Radiomics and Molecular Expression Predictive Model for Esophago-Gastric Junction and Gastric Cancer TRG
An observational study of Gastric Cancer and Adenocarcinoma of the Stomach, run by University of Roma La Sapienza at 5 sites in 2 countries.
Trial summary
The aim of this study is to develop a CT scan-based radiomics predictive model about tumor regression grade (TRG) in patients with esophago-gastric junction (EGJ) ang gastric cancer undergoing perioperative chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Adenocarcinoma of the Stomach
- What is being tested?
- CT scan
- How many people
- 138 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 20 Dec 2019to 30 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with cT2-T4a, cN0-N3, M0 gastric or EGJ cancer who undergo FLOT perioperative chemotherapy followed by radical surgical resection.
Who may be able to join
- Patients with histologically proven adenocarcinoma of the EGJ (Siewert II-III) or stomach.
- Preoperative staging: cT2-T4a, cN0-N3, M0.
- Patients >18 years old.
- Patients undergoing perioperative chemotherapy with Docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil (FLOT).
Who cannot join
- Siewert I EGJ tumor
- Patients undergoing preoperative radiotherapy.
- Absence of both pre and post-chemotherapy CT-scan.
- Patients with tumor progression during preoperative chemotherapy.
- Patients undergoing other neoadjuvant chemotherapy regimen different from FLOT
- Exploratory laparoscopy with positive cytology on the peritoneal lavage or evidence of peritoneal carcinosis
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Italy4 sites
University of Padova
Padova, 35128
Link Campus University
Roma, 00165
Giovanni Maria Garbarino
Roma, 00189
University of Verona
Verona
Netherlands1 site
Amsterdam UMC location University of Amsterdam
Amsterdam, North Holland, 1081 HV
About this study
Official title: CT Scan-Based Radiomics and Molecular Expression Predictive Model to Assess Tumor Regression Grade Following Perioperative Chemotherapy in Esophago-Gastric Junction and Gastric Cancer
The aim of this study is to develop a CT scan-based radiomics predictive model about tumor regression grade (TRG) in patients with esophago-gastric junction (EGJ) ang gastric cancer undergoing perioperative chemotherapy. The molecular expression of the neoplasms will be evaluated to assess its association with the TRG and the radiomic features.
Read the detailed description
- To compare the radiomic features of the CT scans at the time of diagnosis (T0) and at the end of the preoperative chemotherapy (T1) in order to predict the TRG with the texture analysis on the first CT scan.
A non-good response (non-GR) has shown to be predictable with texture analysis on the pre-treatment CT scan.
Therefore, we hypothesize that texture analysis could let to identify the good response patients.
- To find correlation between the molecular expression of the tumor and the radiomics features.
Texture analysis on the pre-chemotherapy CT scan founded that entropy and compactness were higher and uniformity lower in responders. Nonetheless the association between radiomics features and molecular expression has not been investigated yet.
Therefore, we hypothesize to add some others radiomics signatures to the analysis and to find an association with the molecular expression.
- To find correlation between the molecular expression of the tumor and the TRG.
MSI gastric cancer has been shown to be less responsive to preoperative chemotherapy.
Therefore, we hypothesize to confirm this result.
- Conditions
- Gastric Cancer, Adenocarcinoma of the Stomach
- Being tested
- CT scan
- Keywords
- radiomics, molecular expression, perioperative chemotherapy, FLOT, gastric cancer, esophago-gastric junction cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
Also called FLOT chemotherapy, Radical Gastrectomy with D2 Lymphadenectomy, Radical Esophagogastrectomy with D2 Lymphadenectomy
Patients undergoing CT scan staging for gastric and EJ junction cancer + perioperative chemotherapy (FLOT regimen) , CT scan re-staging and radical gastrectomy or esophagogastrectomy will be enrolled in the study
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive performance of radiomics analysis on the pre-treatment CT scan.
Comparing the radiomic features of the CT scans at the time of diagnosis (T0) and at the end of the preoperative chemotherapy (T1) in order to predict the TRG with the texture analysis on the first CT scan.
Measured: 2 months
Secondary outcomes (3)
Association of the radiomics features with the molecular expression of the tumor.
Texture analysis on the pre-chemotherapy CT scan founded that entropy and compactness were higher and uniformity lower in responders. Nonetheless the association between radiomics features and molecular expression has not been investigated yet.
Therefore, we hypothesize to add some others radiomics signatures to the analysis and to find an association with the molecular expression.
Measured: 2 months
Evaluation of the association between TRG and the molecular expression of the tumor.
Investigate if the molecular expression of the tumor can influence the TRG
Measured: 2 months
Association between radiomics and molecular expression in regards to long-term outcomes
Analysis of the 3 and 5y DFS and OS of patients with the radiomics and molecular expression profile
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start20 Dec 2019
- Primary completion1 Oct 2024 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Andrea Laghi
- Responsible party
- Principal investigator, Giovanni Maria Garbarino, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878783
- Sponsor's protocol ID
- URomLS2022
- Status last verified
- May 2024
- First submitted
- 6 May 2021
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Scan-Based Radiomics and Molecular Expression Predictive Model to Assess Tumor Regression Grade Following Perioperative Chemotherapy in Esophago-Gastric Junction and Gastric Cancer
- ClinicalTrials.gov ID
- NCT04878783
- Acronym / sponsor ID
- URomLS2022
- Conditions
- Gastric Cancer, Adenocarcinoma of the Stomach
- Keywords
- radiomics, molecular expression, perioperative chemotherapy, FLOT, gastric cancer, esophago-gastric junction cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Andrea Laghi
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 7 May 2021 (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.
The aim of this study is to develop a CT scan-based radiomics predictive model about tumor regression grade (TRG) in patients with esophago-gastric junction (EGJ) ang gastric cancer undergoing perioperative chemotherapy. The molecular expression of the neoplasms will be evaluated to assess its association with the TRG and the radiomic features.
Detailed description
- To compare the radiomic features of the CT scans at the time of diagnosis (T0) and at the end of the preoperative chemotherapy (T1) in order to predict the TRG with the texture analysis on the first CT scan.
A non-good response (non-GR) has shown to be predictable with texture analysis on the pre-treatment CT scan.
Therefore, we hypothesize that texture analysis could let to identify the good response patients.
- To find correlation between the molecular expression of the tumor and the radiomics features.
Texture analysis on the pre-chemotherapy CT scan founded that entropy and compactness were higher and uniformity lower in responders. Nonetheless the association between radiomics features and molecular expression has not been investigated yet.
Therefore, we hypothesize to add some others radiomics signatures to the analysis and to find an association with the molecular expression.
- To find correlation between the molecular expression of the tumor and the TRG.
MSI gastric cancer has been shown to be less responsive to preoperative chemotherapy.
Therefore, we hypothesize to confirm this result.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with cT2-T4a, cN0-N3, M0 gastric or EGJ cancer who undergo FLOT perioperative chemotherapy followed by radical surgical resection.
Key inclusion criteria (4 listed)
- Patients with histologically proven adenocarcinoma of the EGJ (Siewert II-III) or stomach.
- Preoperative staging: cT2-T4a, cN0-N3, M0.
- Patients >18 years old.
- Patients undergoing perioperative chemotherapy with Docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil (FLOT).
Key exclusion criteria (6 listed)
- Siewert I EGJ tumor
- Patients undergoing preoperative radiotherapy.
- Absence of both pre and post-chemotherapy CT-scan.
- Patients with tumor progression during preoperative chemotherapy.
- Patients undergoing other neoadjuvant chemotherapy regimen different from FLOT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanAlso: FLOT chemotherapy, Radical Gastrectomy with D2 Lymphadenectomy, Radical Esophagogastrectomy with D2 LymphadenectomyPatients undergoing CT scan staging for gastric and EJ junction cancer + perioperative chemotherapy (FLOT regimen) , CT scan re-staging and radical gastrectomy or esophagogastrectomy will be enrolled in the study | Diagnostic test | – |
Primary outcome
Predictive performance of radiomics analysis on the pre-treatment CT scan.
Time frame: 2 months
Comparing the radiomic features of the CT scans at the time of diagnosis (T0) and at the end of the preoperative chemotherapy (T1) in order to predict the TRG with the texture analysis on the first CT scan.
3 secondary outcomes
Association of the radiomics features with the molecular expression of the tumor.
Time frame: 2 months
Evaluation of the association between TRG and the molecular expression of the tumor.
Time frame: 2 months
Association between radiomics and molecular expression in regards to long-term outcomes
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Adenocarcinoma of the Stomach, run by University of Roma La Sapienza at 5 sites in 2 countries.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, 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?
This study is still under way. Results are not available in the source record yet.
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?
Predictive performance of radiomics analysis on the pre-treatment CT scan. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2024.