RecruitingNCT06189898

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

Sponsor

Sebastian Zschaeck

Enrollment

48 participants

Start Date

Dec 15, 2023

Study Type

OBSERVATIONAL

Conditions

Esophagus Cancer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

patients with squamous cell, undifferentiated or adenocarcinoma of the esophagus, UICC stage II-IVA (maximum T4a)
ECOG performace status 0-2
Complete clinical staging, including, esophagogastroscopy, EUS, CT neck/thorax/abdomen and adequate pulmonary function.
Adequate hematological, renal, hepatic and pulmonary functions defined as:
granulocytes ≥ 1.5 x 109/l platelets ≥ 100 x 109/l total bilirubin ≤ 1.5 x upper normal limit creatinine ≤ 120 μmol/L FEV1 ≥ 1.5 L
Written, voluntary informed consent
Willingness to perform effective contraceptive practices during treatment for patients with childbearing potential

Exclusion Criteria4

Evidence of distant metastases (cM1)
Prior high-dose radiotherapy to the thorax or abdomen
Primary tumor cT4b
history or concurrent malignancy as judged by the treating physician. This is only an exclusion criterion if the other malignancy is considered the oncological potentially leading cause of death compared to the esophageal cancer.

Interventions

DIAGNOSTIC_TESTRe Staging FDG-PET

Additional interim FDG-PET during week four of preoperative or definitive chemoradiation for esophageal carcinomas. Evaluation of standardized uptake ratio (SUR) and increased uptake of non tumor affected esophagus (Delta NTO).