Status:
RECRUITING
Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study
Lead Sponsor:
Sebastian Zschaeck
Collaborating Sponsors:
Helmholtz Zentrum Dresden Rossendorf, Dresden, Germany
Conditions:
Esophagus Cancer
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2029
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06189898
Start Date
December 15 2023
End Date
January 31 2029
Last Update
January 5 2024
Active Locations (1)
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1
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353