NCT06408116

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
23mo left

Started Mar 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Mar 2024Apr 2028

First Submitted

Initial submission to the registry

January 4, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

January 4, 2024

Last Update Submit

March 6, 2026

Conditions

Esophagus Cancer, Stage IIEsophagus Cancer, Stage I

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Group 1, Surgery

OTHER

cT1-2 N0, all histologies: primary surgical therapy

Procedure: surgical therapy

Group 2, Chemotherapy and surgery

OTHER

cT3-4 and/or N+, adenocarcinomas: neoadjuvant chemotherapy, surgical therapy

Procedure: surgical therapyDrug: Chemotherapy

Group 3, chemotherapy, radiotherapy and surgery

OTHER

cT3-4 and/or N+, squamous cell carcinomas: neoadjuvant radio(chemo)therapy, surgical therapy

Radiation: photonProcedure: surgical therapyDrug: Chemotherapy

Interventions

ChemotherapyDRUG

neoadjuvant chemotherapy

Group 2, Chemotherapy and surgeryGroup 3, chemotherapy, radiotherapy and surgery
photonRADIATION

radiation with 4-5 cm safte margin

Group 3, chemotherapy, radiotherapy and surgery
surgical therapyPROCEDURE

surgery based on PET-CT/MRI staging

Group 1, SurgeryGroup 2, Chemotherapy and surgeryGroup 3, chemotherapy, radiotherapy and surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiotherapy, University of Heidelberg

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

PhotonsDrug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Elementary ParticlesPhysical PhenomenaLightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaOptical PhenomenaRadiationRadiation, NonionizingTherapeutics

Central Study Contacts

Christoph Fink, MD

CONTACT

+496221 56christoph.find.@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department head

Study Record Dates

First Submitted

January 4, 2024

First Posted

May 9, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)