NCT06189898Recruiting
Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study
Source: ClinicalTrials.gov · Last updated 5 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 48 (estimated)
- First submitted
- 19 Dec 2023
- Start date
- 15 Dec 2023
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Sebastian Zschaeck
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06189898
What you commit to
- Study type: Observational
- Planned participants: 48
- From 15 Dec 2023 to the primary completion date, 31 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior high-dose radiotherapy to the thorax or abdomen
- 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.
Other
- Evidence of distant metastases (cM1)
- Primary tumor cT4b
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité Universitätsmedizin Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.