Registry Platform Gastric/Esophageal Cancer (SAPHIR)

Study Overview
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Brief Summary
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The registry aims to collect and analyse information on the antineoplastic treatment of patients with metastatic esophageal, gastric or gastroesophageal junction cancer, treated in palliative intention in daily routine practice in Germany.

Detailed Description
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SAPHIR is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of metastatic esophageal, gastric or gastroesophageal junction Cancer in Germany. The registry will follow patients for up to two years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Health-related quality of life (HRQoL) will be evaluated for up to two years.

Official Title
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Clinical Research Platform For Molecular Testing, Treatment, Quality Of Life And Outcome Of Patients With Esophageal, Gastric Or Gastroesophageal Junction Cancer Requiring Palliative Systemic Therapy

Conditions
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Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma

Intervention / Treatment
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* Other: Routine care as per site standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven stage IV (metastatic) ESCC, EAC, GAC or GEJAC Planned palliative systemic first-line therapy Age >= 18 years Signed informed consent (IC) Patients answering questionnaires: IC before first therapy cycle Patients not answering questionnaires: IC latest 4 weeks after start of first therapy cycle Exclusion Criteria: No systemic therapy for ESCC, EAC, GAC or GEJAC

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ESCC<br>250 patients with esophageal squamous cell carcinoma | Other: Routine care as per site standard<br>* Physician's choice according to patient's needs. Routine care as per site standard.<br>|
| GAC<br>250 patients with gastric adenocarcinoma | Other: Routine care as per site standard<br>* Physician's choice according to patient's needs. Routine care as per site standard.<br>|
| GEJAC<br>250 patients with gastroesophageal junction adenocarcinoma | Other: Routine care as per site standard<br>* Physician's choice according to patient's needs. Routine care as per site standard.<br>|
| EAC<br>150 patients with esophageal adenocarcinoma | Other: Routine care as per site standard<br>* Physician's choice according to patient's needs. Routine care as per site standard.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of treatment (treatment reality) | Documentation of anamnestic data and therapy sequences | 2 years per patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoplasms, registry, health services research, epidemiology, Germany, palliative treatment, palliative care