Esophagus Cancer, Stage IPhase 2PEGASUSNCT06408116
Predicting Esophageal Cancer Borders Using PET-Imaging
A Phase 2 study testing photon, surgical therapy and Chemotherapy in people with Esophagus Cancer, Stage I and Esophagus Cancer, Stage II, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The study examines the diagnostic precision of endosonography, mpMRI and PET/CT in defining tumor boundaries and tumor spread before and after neoadjuvant therapy and definitive surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Cancer, Stage I, Esophagus Cancer, Stage II
- What is being tested?
- photon, surgical therapy and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2024to Apr 2028
- Phase
- Phase 2
- 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
Who may be able to join
- Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, including AEG I and AEG II tumors in the primary situation
- Planned surgical treatment of esophageal carcinoma
- Possible staging advantage through FAPI PET/CT diagnostics
- Patient information and written consent
- -> KI 60% or ECOG 0/1 (at least: self-sufficiency)
- Age ≥ 18 years
Who cannot join
- Previous radiation therapy in the tumor region
- Previous tumor disease with < 5 years of remission
- Surgical therapy is not functionally or technically possible
- Distant metastasis
- Patient is not capable of giving consent
- Concurrent participation in another clinical trial that could affect the results of this trial or the other trial
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- Illnesses that do not allow the person concerned to assess the nature and scope as well as possible consequences of the clinical study
- pregnant or breastfeeding women
- Signs that the person taking part is unlikely to comply with the therapy (e.g. unwillingness to cooperate)
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
Department of Radiotherapy, University of Heidelberg
Heidelberg, 69120
Juergen Debus, Prof. Dr. Dr., +49 6221 56 ext. 8200, juergen.debus@med.uni-heidelberg.de
Adriane Lentz-Hommertgen, Dr. rer. nat., 0622156 ext. 34091, adriane.lentz-hommertgen@med.uni-heidelberg.de
About this study
Official title: Predicting Esophageal Cancer Borders Using PET-Imaging PEGASUS
The study examines the diagnostic precision of endosonography, mpMRI and PET/CT in defining tumor boundaries and tumor spread before and after neoadjuvant therapy and definitive surgery.
Read the detailed description
In Germany, around 7,100 people develop esophageal cancer every year. The treatment of esophageal cancer depends on the histology in addition to the location and tumor stage. Squamous cell carcinomas are differentiated from adenocarcinomas. Until distant metastases are present in functionally operable patients, the treatment of esophageal cancer includes a curative approach using surgical resection with, depending on the risk profile, neoadjuvant chemotherapy or neoadjuvant radio(chemo)therapy. In patients who are functionally inoperable or who refuse surgery, definitive radio(chemo)therapy is given. While the histopathological frozen section is available for surgical resection to differentiate tumor tissue from healthy tissue in addition to the surgeon's macroscopic impression, this assistance in defining the target volume is missing in radiation oncology. Instead, the target volume definition is based, in addition to the contrast-enhanced CT image, on a pretherapeutic endoscopic marking of the tumor boundaries. This allows the tumor boundaries to be delineated in radiation planning imaging. In order to detect the potential microscopic and lymphonodal tumor spread, a large target volume is necessary as a safety margin to avoid later field edge recurrences. According to the current standard, this safety distance extends 4-5cm in both cranial and caudal directions beyond the actual tumor findings. Due to the close positional relationships in the mediastinum, this procedure leads to radiation exposure and subsequent toxicity to the surrounding risk organs such as the lungs, heart and spinal cord. The aim of the present study is to correlate the preoperative endosonographic and imaging local tumor extension and lymph node involvement with the histopathological tumor extension and, in the case of neoadjuvant treatment, with the treatment response by using modern imaging of the tumor and the tumor microenvironment in patients with operated esophageal carcinoma. Since there cannot be any information about the histological tumor extent as a gold standard in the case of definitive radiotherapy, the data from operated patients obtained in the study are extrapolated to the patient population of definitive radiotherapy. From these data, hypotheses should be generated about which patient (groups) benefit from a reduction in the target volume in the definitive radiotherapy treatment setting and whether modern multimodal imaging is suitable for monitoring the therapy response.
- Being tested
- photon, surgical therapy, Chemotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photonRadiation
radiation with 4-5 cm safte margin
surgical therapyProcedure or surgery
surgery based on PET-CT/MRI staging
ChemotherapyDrug
neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1, Surgery | Other | cT1-2 N0, all histologies: primary surgical therapy Receives: Procedure: surgical therapy |
| Group 2, Chemotherapy and surgery | Other | cT3-4 and/or N+, adenocarcinomas: neoadjuvant chemotherapy, surgical therapy Receives: Procedure: surgical therapy; Drug: Chemotherapy |
| Group 3, chemotherapy, radiotherapy and surgery | Other | cT3-4 and/or N+, squamous cell carcinomas: neoadjuvant radio(chemo)therapy, surgical therapy Receives: Radiation: photon; Procedure: surgical therapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor expansion
Number of patients with correlation of tumor expansion measured by histopathology and imaging techniques (Pet-CT)
Measured: Before the start of therapy an immediately after the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Mar 2024
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus Cancer, Stage IStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408116
- Sponsor's protocol ID
- RADONK-PEGASUS-2023
- Acronym
- PEGASUS
- Status last verified
- Mar 2026
- First submitted
- 4 Jan 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Esophageal Cancer Borders Using PET-Imaging PEGASUS
- ClinicalTrials.gov ID
- NCT06408116
- Acronym / sponsor ID
- PEGASUS / RADONK-PEGASUS-2023
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 9 May 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.
The study examines the diagnostic precision of endosonography, mpMRI and PET/CT in defining tumor boundaries and tumor spread before and after neoadjuvant therapy and definitive surgery.
Detailed description
In Germany, around 7,100 people develop esophageal cancer every year. The treatment of esophageal cancer depends on the histology in addition to the location and tumor stage. Squamous cell carcinomas are differentiated from adenocarcinomas. Until distant metastases are present in functionally operable patients, the treatment of esophageal cancer includes a curative approach using surgical resection with, depending on the risk profile, neoadjuvant chemotherapy or neoadjuvant radio(chemo)therapy. In patients who are functionally inoperable or who refuse surgery, definitive radio(chemo)therapy is given. While the histopathological frozen section is available for surgical resection to differentiate tumor tissue from healthy tissue in addition to the surgeon's macroscopic impression, this assistance in defining the target volume is missing in radiation oncology. Instead, the target volume definition is based, in addition to the contrast-enhanced CT image, on a pretherapeutic endoscopic marking of the tumor boundaries. This allows the tumor boundaries to be delineated in radiation planning imaging. In order to detect the potential microscopic and lymphonodal tumor spread, a large target volume is necessary as a safety margin to avoid later field edge recurrences. According to the current standard, this safety distance extends 4-5cm in both cranial and caudal directions beyond the actual tumor findings. Due to the close positional relationships in the mediastinum, this procedure leads to radiation exposure and subsequent toxicity to the surrounding risk organs such as the lungs, heart and spinal cord. The aim of the present study is to correlate the preoperative endosonographic and imaging local tumor extension and lymph node involvement with the histopathological tumor extension and, in the case of neoadjuvant treatment, with the treatment response by using modern imaging of the tumor and the tumor microenvironment in patients with operated esophageal carcinoma. Since there cannot be any information about the histological tumor extent as a gold standard in the case of definitive radiotherapy, the data from operated patients obtained in the study are extrapolated to the patient population of definitive radiotherapy. From these data, hypotheses should be generated about which patient (groups) benefit from a reduction in the target volume in the definitive radiotherapy treatment setting and whether modern multimodal imaging is suitable for monitoring the therapy response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1, Surgery | Other | Procedure: surgical therapycT1-2 N0, all histologies: primary surgical therapy |
| Group 2, Chemotherapy and surgery | Other | Procedure: surgical therapy, Drug: ChemotherapycT3-4 and/or N+, adenocarcinomas: neoadjuvant chemotherapy, surgical therapy |
| Group 3, chemotherapy, radiotherapy and surgery | Other | Radiation: photon, Procedure: surgical therapy, Drug: ChemotherapycT3-4 and/or N+, squamous cell carcinomas: neoadjuvant radio(chemo)therapy, surgical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, including AEG I and AEG II tumors in the primary situation
- Planned surgical treatment of esophageal carcinoma
- Possible staging advantage through FAPI PET/CT diagnostics
- Patient information and written consent
- -> KI 60% or ECOG 0/1 (at least: self-sufficiency)
Key exclusion criteria (9 listed)
- Previous radiation therapy in the tumor region
- Previous tumor disease with < 5 years of remission
- Surgical therapy is not functionally or technically possible
- Distant metastasis
- Patient is not capable of giving consent
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 |
|---|---|---|
| photonradiation with 4-5 cm safte margin | Radiation | Group 3, chemotherapy, radiotherapy and surgery |
| surgical therapysurgery based on PET-CT/MRI staging | Procedure or surgery | Group 1, Surgery, Group 2, Chemotherapy and surgery, Group 3, chemotherapy, radiotherapy and surgery |
| Chemotherapyneoadjuvant chemotherapy | Drug | Group 2, Chemotherapy and surgery, Group 3, chemotherapy, radiotherapy and surgery |
Primary outcome
Tumor expansion
Time frame: Before the start of therapy an immediately after the therapy
Number of patients with correlation of tumor expansion measured by histopathology and imaging techniques (Pet-CT)
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 10 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing photon, surgical therapy and Chemotherapy in people with Esophagus Cancer, Stage I and Esophagus Cancer, Stage II, run by University Hospital Heidelberg 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 6 inclusion and 9 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 10 Mar 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Christoph Fink, MD (+496221 56 ext. 8201, christoph.find.@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor expansion (time frame: Before the start of therapy an immediately after the therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2026.