GALERAS
Research type
Research Study
Full title
A Multi-Country Observational Chart Review Study to Characterize Treatment Patterns and Clinical Outcomes among Patients with Resectable Gastric or Gastroesophageal Junction Cancer
IRAS ID
351011
Contact name
VISHAL PATEL
Contact email
Sponsor organisation
ASTRAZENECA UK LIMITED
Duration of Study in the UK
0 years, 4 months, 2 days
Research summary
This is a multi-country, multi-site, non-interventional, observational study,
with retrospective data collection to describe neoadjuvant and adjuvant treatment patterns for patients diagnosed with resectable GC or GEJC, as a primary objective.
Comparison of selected patient and tumor characteristics according to neoadjuvant and/or adjuvant treatment regimens, including FLOT, chemoradiotherapy, other chemotherapy, and no treatment, as well as descriptions of neoadjuvant/adjuvant treatment outcomes including surgical response, real-world event-free survival, real-world recurrence-free survival, overall survival, treatment duration, and time to next treatment, reported overall and by treatment regimen (sample size permitting) are targeted at secondary objectives. The study will be conducted in cancer treatment centers in 7 countries, including Hong Kong, France, Germany, Japan, South Korea, the United Kingdom, and Australia and it is expected to comprise a minimum of 100 patients from each country. The study period will be between 1st January 2018 and 1st May 2023. Adult patients (≥18 years) patients at the index date (date of diagnosis)
with clinically confirmed resectable GC or GEJC between 1st January 2018 and 1st May 2023 will be eligible for the study (data collection). Those patients with any other cancer diagnosis recorded before index date, or/and patients enrolled in a randomized clinical trial at the index date or at the time of non-metastatic cancer treatment (neoadjuvant, surgery, adjuvant treatment), and/or with missing age or
sex won´t be eligible for the study as well as, those patients who received cancer treatment (neoadjuvant, surgery, adjuvant) at different treatment sites from the participating site and for whom treatment data is unavailable.All analyses will be descriptive in nature except for analyses relating to secondary objective 1 in which patient characteristics and outcomes will be described according to neoadjuvant and adjuvant treatment regimen.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
24/PR/1414
Date of REC Opinion
21 Nov 2024
REC opinion
Favourable Opinion