Using imaging to identify sensitive esophageal cancer for better treatment
Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study
This study is testing if special imaging can help find esophageal cancer that responds well to treatment, so doctors can give more personalized care to patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06189898 on ClinicalTrials.gov |
What this trial studies
This observational trial investigates the use of advanced FDG-PET imaging parameters to identify squamous cell carcinomas of the esophagus that are highly sensitive to chemoradiation therapy. The study aims to validate biomarkers that could allow for more personalized treatment approaches, such as organ preservation for patients who respond well to therapy. Key endpoints include event-free survival and quality of life assessments, with additional focus on genetic sequencing to optimize future treatments for non-responders. The trial includes patients with various stages of esophageal cancer undergoing definitive chemoradiation.
Who should consider this trial
Good fit: Ideal candidates include patients with squamous cell, undifferentiated, or adenocarcinoma of the esophagus at UICC stage II-IVA with a performance status of 0-2.
Not a fit: Patients with evidence of distant metastases or prior high-dose radiotherapy to the thorax or abdomen may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored treatment strategies for esophageal cancer patients, improving outcomes and quality of life.
How similar studies have performed: Other studies have shown promise in using imaging biomarkers for treatment response, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Berlin
- Charité Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Sebastian Zschaeck, MD — Charite University, Berlin, Germany
- Study coordinator: Sebastian Zschaeck, MD
- Email: sebastian.zschaeck@charite.de
- Phone: ++4930450650764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.