NCT04878783

Brief 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. The molecular expression of the neoplasms will be evaluated to assess its association with the TRG and the radiomic features.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
active not recruiting

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

Study Progress81%
Dec 2019Oct 2027

Study Start

First participant enrolled

December 20, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2027

Expected
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

4.8 years

First QC Date

May 6, 2021

Last Update Submit

May 8, 2024

Conditions

Gastric CancerAdenocarcinoma of the Stomach

Keywords

radiomicsmolecular expressionperioperative chemotherapyFLOTgastric canceresophago-gastric junction cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months

Secondary Outcomes (3)

  • Association of the radiomics features with the molecular expression of the tumor.

    2 months

  • Evaluation of the association between TRG and the molecular expression of the tumor.

    2 months

  • Association between radiomics and molecular expression in regards to long-term outcomes

    5 years

Interventions

CT scanDIAGNOSTIC_TEST

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

Also known as: FLOT chemotherapy, Radical Gastrectomy with D2 Lymphadenectomy, Radical Esophagogastrectomy with D2 Lymphadenectomy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cT2-T4a, cN0-N3, M0 gastric or EGJ cancer who undergo FLOT perioperative chemotherapy followed by radical surgical resection.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Padova

Padua, 35128, Italy

Location

Link Campus University

Roma, 00165, Italy

Location

Giovanni Maria Garbarino

Roma, 00189, Italy

Location

University of Verona

Verona, Italy

Location

Amsterdam UMC location University of Amsterdam

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gastrectomy or esophagogastrectomy specimen

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 7, 2021

Study Start

December 20, 2019

Primary Completion

October 1, 2024

Study Completion (Estimated)

October 30, 2027

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

NL(1)IT(4)