Combined tumor plus nontumor interim FDG-PET parameters are prognostic for response to chemoradiation in squamous cell esophageal cancer.
Sebastian Zschaeck, Yimin Li, Rebecca Bütof...
https://pubmed.ncbi.nlm.nih.gov/32010957Actively Recruiting
Age: 18Years +
All Genders
ID06189898
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
N/A
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
Researchers are investigating new imaging methods to identify esophageal squamous cell carcinomas that respond well to chemoradiation therapy (CRT). The study focuses on validating innovative FDG-PET scan parameters taken during treatment to detect tumors highly sensitive to CRT. The goal is to improve individualized treatment approaches, potentially preserving organs in patients who respond well to CRT. The main measure is event-free survival, with additional focus on quality of life, side effects, overall survival, local control, and distant metastases. The study involves an additional FDG-PET scan during the fourth week of preoperative or definitive chemoradiation to assess tumor metabolic activity using specific parameters like SURmax and DeltaNTO. Besides imaging, genetic sequencing of tumor tissue aims to find targetable mutations linked to treatment response, supporting future biology-based treatment improvements. An observational arm includes patients with esophageal adenocarcinoma to explore whether the imaging biomarkers apply beyond squamous cell carcinoma. Another program will establish tumor cell cultures to better understand imaging biomarkers and mutation-driven treatments. Participants will undergo standard clinical staging and functional assessments before and during treatment. Researchers will monitor progression-free survival over two years, along with overall survival and recurrence-free survival. The study includes assessments of quality of life and side effects. Participants may provide tumor tissue samples for genetic analysis. The total follow-up period is two years, during which imaging results and clinical outcomes will be carefully evaluated to validate the biomarker and support personalized treatment strategies.
CONDITIONS
Brief Title
Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with squamous cell, undifferentiated, or adenocarcinoma of the esophagus, UICC stage II to IVA (maximum T4a)
- ECOG performance status 0 to 2
- Complete clinical staging including esophagogastroscopy, endoscopic ultrasound, CT of neck/thorax/abdomen, and adequate lung function
- Adequate blood, kidney, liver, and lung function: granulocytes ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, total bilirubin ≤ 1.5 times upper normal limit, creatinine ≤ 120 µmol/L, FEV1 ≥ 1.5 L
- Written voluntary informed consent
- Willingness to use effective contraception during treatment if of childbearing potential
You will not qualify if you...
- Evidence of distant metastases (cM1)
- Prior high-dose radiotherapy to the chest or abdomen
- Primary tumor classified as cT4b
- History or concurrent cancer judged by the physician to be a greater risk than the esophageal cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Complete clinical staging including esophagogastroscopy, endoscopic ultrasound, CT scans, and lung function tests.
Diagnostic Evaluation
Duration - 1 day during week four of chemoradiation
Participants undergo an additional interim FDG-PET scan during week four of chemoradiation to evaluate tumor response and imaging biomarkers.
1 visit (in-person) for FDG-PET scan
Long-term Monitoring
Duration - Up to 2 years
Participants are monitored continuously for progression-free survival, overall survival, and recurrence for up to two years following chemoradiation.
Follow-up visits as scheduled for up to 2 years
Trial Site Locations
Total: 1 location
1
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
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Research Team
S
Sebastian Zschaeck, MD
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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