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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
  • 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

    Recruiting

Other trials in Germany

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 groups in NCT06408116
Study groupRoleWhat they receive
Group 1, SurgeryOthercT1-2 N0, all histologies: primary surgical therapy
Receives: Procedure: surgical therapy
Group 2, Chemotherapy and surgeryOthercT3-4 and/or N+, adenocarcinomas: neoadjuvant chemotherapy, surgical therapy
Receives: Procedure: surgical therapy; Drug: Chemotherapy
Group 3, chemotherapy, radiotherapy and surgeryOthercT3-4 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.

  1. 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.

  1. First posted9 May 2024
  2. Study start1 Mar 2024
  3. Primary completionJan 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

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)
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

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.

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