Pilot study on the introduction of standardized, pre-therapeutic endoscopy, possibly with marker implantation (BioXmark), in patients with esophageal cancer and primary curative therapy intention at the NCT/UCC.

Pilot study on the introduction of standardized, pre-therapeutic endoscopy, possibly with marker implantation (BioXmark), in patients with esophageal cancer and primary curative therapy intention at the NCT/UCC. - EVI2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025428

Enrollment

Registered

2021-10-25

Start date

2022-01-25

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C15.9

Interventions

Group 1: During endosonography of the esophagus, a CE-certified but novel liquid marker is injected around the primary tumor to demarcate it. In subsequent imaging to delineate the target volume, i.e.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - histologically confirmed tumor - Patients with cT2 N0 M0 tumors suitable for primary resection - Patients with cT2-4 N+ M0 tumors suitable for neoadjuvant radiochemotherapy (40-41.4 Gy) followed by resection - Patients with cT2-4 N+ M0 tumors who are eligible for primary definitive radiochemotherapy due to co-morbidities or patient preference - Complete stenosis of the esophagus has been excluded. - Written informed consent from the patient.

Exclusion criteria

Exclusion criteria: - Presence of distant metastases - Patients who are not suitable for curative treatment.

Design outcomes

Primary

Measure	Time frame
Primary endpoint: safety of marker implantation. The review will be performed one week after marker implantation. Any side effects will be recorded.	—

Countries

Germany

Contacts

Public ContactLuisa Schünzel

Universitätsklinikum Carl Gustav Carus Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie

str.studien@uniklinikum-dresden.de+49 351-458 13390

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026