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Trial Title:
Predicting Esophageal Cancer Borders Using PET-Imaging
NCT ID:
NCT06408116
Condition:
Esophagus Cancer, Stage I
Esophagus Cancer, Stage II
Conditions: Official terms:
Esophageal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
photon
Description:
radiation with 4-5 cm safte margin
Arm group label:
Group 3, chemotherapy, radiotherapy and surgery
Intervention type:
Procedure
Intervention name:
surgical therapy
Description:
surgery based on PET-CT/MRI staging
Arm group label:
Group 1, Surgery
Arm group label:
Group 2, Chemotherapy and surgery
Arm group label:
Group 3, chemotherapy, radiotherapy and surgery
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
neoadjuvant chemotherapy
Arm group label:
Group 2, Chemotherapy and surgery
Arm group label:
Group 3, chemotherapy, radiotherapy and surgery
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.
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Radiotherapy, University of Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Juergen Debus, Prof. Dr. Dr.
Phone:
+49 6221 56
Phone ext:
8200
Email:
juergen.debus@med.uni-heidelberg.de
Contact backup:
Last name:
Adriane Lentz-Hommertgen, Dr. rer. nat.
Phone:
0622156
Phone ext:
34091
Email:
adriane.lentz-hommertgen@med.uni-heidelberg.de
Start date:
March 1, 2024
Completion date:
April 2026
Lead sponsor:
Agency:
University Hospital Heidelberg
Agency class:
Other
Source:
University Hospital Heidelberg
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06408116
