Esophagus CancerFIRASENCT06189898
Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study
An observational study of Esophagus Cancer, run by Sebastian Zschaeck at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- Re Staging FDG-PET
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 15 Dec 2023to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For the primary endpoint only patients with squamous cell histology will be evaluated. Patients with adenocarcinomas will be used as exploratory cohort.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, 13353
Sebastian Zschaeck, MD
About this study
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.
Read the detailed 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.
- Conditions
- Esophagus Cancer
- Being tested
- Re Staging FDG-PET
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re Staging FDG-PETDiagnostic test
Also called [18F]Fluorodeoxyglucose positron emission tomograhpy at week four radiochemotherapy
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
progression free survival is defined as any tumor recurrence (local, regional and or distant) or death
Measured: continiously with two year follow up
Secondary outcomes (2)
Overall survival
death of patients
Measured: continiously with two year follow up
loco-regional recurrence free survival
time without local or regional tumor recurrence
Measured: continiously with two year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start15 Dec 2023
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sebastian Zschaeck
- Sponsor type
- University, hospital or other
- Collaborators
- Helmholtz Zentrum Dresden Rossendorf, Dresden, Germany
- Responsible party
- Sponsor-investigator, Sebastian Zschaeck, Charite University, Berlin, Germany
- Investigators
- Sebastian Zschaeck, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189898
- Sponsor's protocol ID
- FIRASE
- Acronym
- FIRASE
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32010957
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study
- ClinicalTrials.gov ID
- NCT06189898
- Acronym / sponsor ID
- FIRASE / FIRASE
- Conditions
- Esophagus Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sebastian ZschaeckUniversity, hospital or other
- Collaborators
- Helmholtz Zentrum Dresden Rossendorf, Dresden, Germany
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For the primary endpoint only patients with squamous cell histology will be evaluated. Patients with adenocarcinomas will be used as exploratory cohort.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re Staging FDG-PETAlso: [18F]Fluorodeoxyglucose positron emission tomograhpy at week four radiochemotherapyAdditional 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). | Diagnostic test | – |
Primary outcome
Progression free survival
Time frame: continiously with two year follow up
progression free survival is defined as any tumor recurrence (local, regional and or distant) or death
2 secondary outcomes
Overall survival
Time frame: continiously with two year follow up
loco-regional recurrence free survival
Time frame: continiously with two year follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 32010957Zschaeck 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastian Zschaeck, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagus Cancer, run by Sebastian Zschaeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Zschaeck, MD (++4930450650764, sebastian.zschaeck@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: continiously with two year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06189898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.