Pilot study for the introduction of standardized, pretherapeutic endoscopy, possibly with marker implantation (Visicoil), in patients with esophageal carcinoma eligible for primary therapy with curative intent at UCC Dresde

Not Applicable

• Conditions: C15.1; C15.2; C15.3; C15.4; C15.5; C15.8; Thoracic part of oesophagus; Abdominal part of oesophagus; Upper third of oesophagus; Middle third of oesophagus

• Registration Number: DRKS00011886
• Lead Sponsor: niversitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-31
• Study Completion: 2018-08-01
• Results First Posted: 2024-05-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• histologically confirmed tumor
• Patients with cT2 N0 M0 tumors that are suitable for primary resection
• Patients with cT2-4 N + M0 tumors suitable for neoadjuvant radiochemotherapy (41.4 Gy) followed by resection
• Patients with cT2-4 N + M0 tumors that are eligible for primary radiochemotherapy due to co-morbidities or patient requirements
• Complete stenosis of the esophagus was excluded
• written patient consent

Exclusion Criteria

• Presence of distant metastases
• Patients who are not suitable for curative treatment

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implementation of endoscopy with possible gold marker implantation as a feasible, safe, pretherapeutic diagnostic method.

Secondary Outcome Measures

Name	Time	Method
• Toxicity / AE (CTCAE 4.0) after implantation of the Visicoil” markers<br>• Number and position of the injected Markers<br>• Visibility of the markers and their geometrical stability prior to and during treatment on routinely performed FDG-PET/CT imaging and on weekly control-CT in patients undergoing proton irradiation. <br>