Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study — FIRASE  

Esophagus Cancer Clinical Trial

Official title: Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study

Status Recruiting

Clinical Trial Summary

This trial on biomarker validation investigates the use of innovative re-staging FDG-PET parameters to detect highly chemoradiation (CRT) sensitive squamous cell carcinomas of the esophagus (SCEC) at the end of preoperative or definitive CRT.

Clinical Trial Description

This trial on biomarker validation investigates the use of innovative re-staging FDG-PET parameters to detect highly chemoradiation (CRT) sensitive squamous cell carcinomas of the esophagus (SCEC) at the end of preoperative or definitive CRT. Successful validation of this biomarker could lead to a more individualized approach for patients, i.e. organ preservation in highly chemoradiosensitive patients. Since favorable response to CRT is associated with better outcome of patients, the primary endpoint of the study is an improved event-free-survival (EFS) in responders receiving definitive CRT compared to non-responders. Additional quality of life and other important endpoints (side effects, overall survival, local control, occurrence of distant metastases) will be assessed in both treatment groups.

The investigated PET parameters are Maximum standardized uptake ratio (SURmax) of the primary tumor at week four of chemoradiation and change of maximum standardized uptake value of the non tumor affected esophagus (DeltaNTO).

To improve the treatment in non-responders in future trials, the study has two additional scientific support programmes included: Genetic sequencing of tumor tissue to identify targetable mutations and correlate these with novel imaging biomarkers of none-response on the one hand (biology based treatment optimization). On the other hand the study will include an additional observational study arm. In this arm patients with adenocarcinoma of the esophagus can be included. Our biomarker has only been established in squamous cell carcinomas, therefore it is an interesting exploratory question, if the parameter can also be applied to patients with adenocarcinomas of the esophagus. An additional scientific support program will establish primary tumor cells for better mechanistical understanding of the imaging biomarkers and testing of treatment according to targetable mutations. ;

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

• NCT number: NCT06189898
• Study type: Observational
• Source: Charite University, Berlin, Germany
• Contact: Sebastian Zschaeck, MD
• Phone: ++4930450650764
• Email: sebastian.zschaeck@charite.de
• Status: Recruiting
• Start date: December 15, 2023
• Completion date: January 31, 2029