Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study

Esophagus Cancer Clinical Trial

— FIRASE  

Official title:

Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189898
• Other study ID #: FIRASE
• Status: Recruiting
• Start date: December 15, 2023
• Est. completion date: January 31, 2029

Study information

• Verified date: December 2023
• Source: Charite University, Berlin, Germany
• Contact: Sebastian Zschaeck, MD
• Phone: ++4930450650764
• Email: sebastian.zschaeck[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 the end of preoperative or definitive CRT.

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 the end of preoperative or definitive CRT. Successful validation of this biomarker could lead to a more individualized approach for patients, i.e. organ preservation in highly chemoradiosensitive patients. Since favorable response to CRT is associated with better outcome of patients, the primary endpoint of the study is an improved event-free-survival (EFS) in responders receiving definitive CRT compared to non-responders. Additional quality of life and other important endpoints (side effects, overall survival, local control, occurrence of distant metastases) will be assessed in both treatment groups. The investigated PET parameters are Maximum standardized uptake ratio (SURmax) of the primary tumor at week four of chemoradiation and change of maximum standardized uptake value of the non tumor affected esophagus (DeltaNTO). To improve the treatment in non-responders in future trials, the study has two additional scientific support programmes included: Genetic sequencing of tumor tissue to identify targetable mutations and correlate these with novel imaging biomarkers of none-response on the one hand (biology based treatment optimization). On the other hand the study will include an additional observational study arm. In this arm patients with adenocarcinoma of the esophagus can be included. Our biomarker has only been established in squamous cell carcinomas, therefore it is an interesting exploratory question, if the parameter can also be applied to patients with adenocarcinomas of the esophagus. An additional scientific support program will establish primary tumor cells for better mechanistical understanding of the imaging biomarkers and testing of treatment according to targetable mutations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 31, 2029
• Est. primary completion date: January 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Diagnostic Test:
• Re Staging FDG-PET
Additional interim FDG-PET during week four of preoperative or definitive chemoradiation for esophageal carcinomas. Evaluation of standardized uptake ratio (SUR) and increased uptake of non tumor affected esophagus (Delta NTO).

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Sebastian Zschaeck	Helmholtz Zentrum Dresden Rossendorf, Dresden, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Zschaeck 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	progression free survival is defined as any tumor recurrence (local, regional and or distant) or death	continiously with two year follow up
Secondary	Overall survival	death of patients	continiously with two year follow up
Secondary	loco-regional recurrence free survival	time without local or regional tumor recurrence	continiously with two year follow up