Predicting Esophageal Cancer Borders Using PET-Imaging (PEGASUS)

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.

Study Overview

• Status: Recruiting
• Conditions: Esophagus Cancer, Stage I; Esophagus Cancer, Stage II
• Intervention / Treatment: Procedure: surgical therapy; Drug: Chemotherapy; Radiation: photon

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christoph Fink, MD; Phone Number: 8201 +496221 56; Email: christoph.find.@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • Department of Radiotherapy, University of Heidelberg
    • Contact: Juergen Debus, Prof. Dr. Dr.; Phone Number: 8200 +49 6221 56; Email: juergen.debus@med.uni-heidelberg.de
    • Contact: Adriane Lentz-Hommertgen, Dr. rer. nat.; Phone Number: 34091 0622156; Email: adriane.lentz-hommertgen@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1, Surgery; cT1-2 N0, all histologies: primary surgical therapy	Procedure: surgical therapy; surgery based on PET-CT/MRI staging
Other: Group 2, Chemotherapy and surgery; cT3-4 and/or N+, adenocarcinomas: neoadjuvant chemotherapy, surgical therapy	Procedure: surgical therapy; surgery based on PET-CT/MRI staging; Drug: Chemotherapy; neoadjuvant chemotherapy
Other: Group 3, chemotherapy, radiotherapy and surgery; cT3-4 and/or N+, squamous cell carcinomas: neoadjuvant radio(chemo)therapy, surgical therapy	Procedure: surgical therapy; surgery based on PET-CT/MRI staging; Drug: Chemotherapy; neoadjuvant chemotherapy; Radiation: photon; radiation with 4-5 cm safte margin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor expansion	Number of patients with correlation of tumor expansion measured by histopathology and imaging techniques (Pet-CT)	Before the start of therapy an immediately after the therapy

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Therapeutics; Physical Phenomena; Electromagnetic Phenomena; Magnetic Phenomena; Electromagnetic Radiation; Radiation; Elementary Particles; Light; Optical Phenomena; Radiation, Nonionizing; Drug Therapy; Photons
• Other Study ID Numbers: RADONK-PEGASUS-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No