Actively Recruiting
Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study
Led by Sebastian Zschaeck · Updated on 2024-01-05
48
Participants Needed
1
Research Sites
267 weeks
Total Duration
On this page
Sponsors
S
Sebastian Zschaeck
Lead Sponsor
H
Helmholtz Zentrum Dresden Rossendorf, Dresden, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with squamous cell, undifferentiated, or adenocarcinoma of the esophagus, UICC stage II-IVA (maximum T4a)
- ECOG performance status 0-2
- Complete clinical staging including esophagogastroscopy, endoscopic ultrasound, CT of neck, thorax, and abdomen, and adequate pulmonary function
- Adequate hematological, renal, hepatic, and pulmonary functions defined by granulocytes 21 1.5 x 10^9/l, platelets 21 100 x 10^9/l, total bilirubin 24 1.5 times upper normal limit, creatinine 24 120 bcmol/L, and FEV1 21 1.5 L
- Written, voluntary informed consent
- Willingness to practice effective contraception during treatment for patients with childbearing potential
You will not qualify if you...
- Evidence of distant metastases (cM1)
- Prior high-dose radiotherapy to the thorax or abdomen
- Primary tumor classified as cT4b
- History or concurrent malignancy considered by the treating physician to be the oncological leading cause of death compared to the esophageal cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
Research Team
S
Sebastian Zschaeck, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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