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
Overview
- Phase
- N/A
- Intervention
- Routine care as per site standard
- Conditions
- Esophageal Squamous Cell Carcinoma
- Sponsor
- iOMEDICO AG
- Enrollment
- 1900
- Locations
- 1
- Primary Endpoint
- Course of treatment (treatment reality)
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
ESCC
250 patients with esophageal squamous cell carcinoma
Intervention: Routine care as per site standard
GAC
920 patients with gastric adenocarcinoma
Intervention: Routine care as per site standard
GEJAC
580 patients with gastroesophageal junction adenocarcinoma
Intervention: Routine care as per site standard
EAC
150 patients with esophageal adenocarcinoma
Intervention: Routine care as per site standard
Outcomes
Primary Outcomes
Course of treatment (treatment reality)
Time Frame: 2 years per patient
Documentation of anamnestic data and therapy sequences