Clinical trial · Observational
Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study
NCT06189898CI-TRIAL-00072751FIRASErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophagus Cancer | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Re Staging FDG-PET | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- continiously with two year follow up
- description
- progression free survival is defined as any tumor recurrence (local, regional and or distant) or death
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- continiously with two year follow up
- description
- death of patients
- measure
- loco-regional recurrence free survival
- timeFrame
- continiously with two year follow up
- description
- time without local or regional tumor recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDZschaeck S, Li Y, Butof R, Lili C, Hua W, Troost ECG, Beck M, Amthauer H, Kaul D, Kotzerke J, Baur ADJ, Ghadjar P, Baumann M, Krause M, Hofheinz F. Combined tumor plus nontumor interim FDG-PET parameters are prognostic for response to chemoradiation in squamous cell esophageal cancer. Int J Cancer. 2020 Sep 1;147(5):1427-1436. doi: 10.1002/ijc.32897. Epub 2020 Feb 19. PMID 32010957