A Study in Greece Observing How Patients With Stomach and Esophageal Cancer Are Diagnosed and Treated in Everyday Medical Practice

NCT07800754 | Not Yet Recruiting

• 1 other identifier: D133HR00065
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a retrospective-prospective observational, multicenter, single-country study aiming to describe the epidemiological characteristics and management strategies in patients with stage II-IVB gastric/GEJ adenocarcinoma in routine clinical practice in Greece.

Conditions

Gastric Cancer; Gastroesophageal Junction Cancer

Keywords

Gastric Cancer; Gastroesophageal Junction Cancer; Adenocarcinoma; Observational Study; Real-World Evidence; Epidemiology; Treatment Patterns; Greece

Outcome Measures

Primary Outcomes (11)

• Distribution of GC/GEJ cancer types

  Percentage of GC/GEJ cancer types (adenocarcinoma, squamous cell carcinoma, other).

  Measured at baseline, during patients 1st visit.

• Clinicopathological characteristics of patients with histologically confirmed stage II to IVB gastric/GEJ cancer.

  Patient and disease characteristics at diagnosis for patients with histologically confirmed stage II to IVB GC/GEJ adenocarcinoma.

  Measured at baseline, during patients 1st visit.

• To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.

  To describe current treatment modalities (surgery, systemic therapy, radiotherapy, chemoradiation (CRT) and palliative care) applied in the resectable (Stages II-IVA) and advanced/metastatic (Stage IVB) settings, presented as types

  Up to 18 months ± 30 days (through study completion)

• To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma, measured as frequencies per stage

  To describe current treatment modalities (surgery, systemic therapy, radiotherapy, chemoradiation (CRT) and palliative care) applied in the resectable (Stages II-IVA) and advanced/metastatic (Stage IVB) settings, presented as frequencies per stage.

  Up to 18 months ± 30 days (through study completion)

• Estimation of key time intervals, measured by time (months) from diagnosis to neoadjuvant or perioperative treatment and/or surgery (if applicable)

  To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating key time intervals, including time (months) from diagnosis to neoadjuvant or perioperative treatment and/or surgery (if applicable).

  Up to 18 months ± 30 days (through study completion)

• Estimation of key time intervals, measured by time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA)

  To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimation of key time intervals, including time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA)

  Up to 18 months ± 30 days (through study completion)

• Estimation of key time intervals, measured by time (months) from first to second-line.

  To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating key time intervals, including time (months) from first to second-line.

  Up to 18 months ± 30 days (through study completion)

• Estimation of key time intervals, measured by time (months) from second-line to third-line systemic treatment (for Stage IVB).

  To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating key time intervals, including time (months) from second-line to third-line systemic treatment (for Stage IVB).

  Up to 18 months ± 30 days (through study completion)

• Duration of each systemic treatment line (overall and by type: chemotherapy, targeted therapy/immunotherapy; up to 3rd line)

  To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating the duration of each systemic treatment line (overall and by type: chemotherapy, targeted therapy/immunotherapy; up to 3rd line)

  Up to 18 months ± 30 days (through study completion)

• Description of dosing schemes

  To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by describing dosing schemes.

  Up to 18 months ± 30 days (through study completion)

• To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.

  To describe treatment sequences.

  Up to 18 months ± 30 days (through study completion)

Secondary Outcomes (5)

• Pathologic complete response (pCR) rate

  Up to 18 months ± 30 days (through study completion)

• Description of types of biomarkers tested at diagnosis, by disease stage (II-IVA, IVB).

  Up to 18 months ± 30 days (through study completion)

• Percentage of patients tested for biomarkers.

  Up to 18 months ± 30 days (through study completion)

• Percentage of positive results by biomarker type.

  Up to 18 months ± 30 days (through study completion)

• Time from diagnosis to biomarker results captured during biomarkers testing by disease stage (II-IVA, IVB).

  Up to 18 months ± 30 days (through study completion)

Study Arms (1)

Patients with Stage II-IVB Gastric/GEJ Adenocarcinoma

Adult patients with histologically confirmed, stage II to IVB gastric/GEJ adenocarcinoma will be enrolled from 10-15 oncology clinics of large public and private hospitals, covering diverse geographic areas, in Greece. Eligible patients will have been diagnosed between June 1st, 2025 and the end of the recruitment period (Q3 2027). The study includes both retrospective and prospective components.

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 300 adult patients with histologically confirmed, stage II to IVB gastric/GEJ adenocarcinoma will be enrolled from 10-15 oncology clinics of large public and private hospitals, covering diverse geographic areas, in Greece.

You may qualify if:

• Patients aged ≥18 years upon gastric/GEJ adenocarcinoma diagnosis.
• Written signed and dated informed consent by the patient (or their legally acceptable representative, as applicable). For deceased patients on the date of study entry a waiver of consent must be approved by the Hospital EC/IRB.
• Patients diagnosed with histologically confirmed, stage II to IVB adenocarcinoma of gastric/GEJ, between June 1st, 2025 and the end of the recruitment period (Q3 2027).

You may not qualify if:

• Patients who participate or participated during the data collection period (prospective and retrospective) in any clinical investigation/clinical trial that includes interventions that fall outside the everyday clinical practice.
• Patients who have participated in the design and/or the conduct of the study.
• Patients with another primary malignancy within the last 5 years, for which systemic anticancer treatment is required after the diagnosis of gastric/GEJ cancer.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Stomach Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 2, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIPhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.