Functional Imaging to Identify Radiosensitive Esophageal Cancer - a Biomarker Validation Study

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06189898

Studienbeginn:
Dezember 2023

Letztes Update:
05.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Esophageal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Sebastian Zschaeck

Collaborator:
Helmholtz Zentrum Dresden Rossendorf, Dresden, Germany

Studienleiter

Sebastian Zschaeck, MD
Principal Investigator
Charite University, Berlin, Germany

Kontakt

Sebastian Zschaeck, MD
Kontakt:
Phone: ++4930450650764
E-Mail: sebastian.zschaeck@charite.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Charité Universitätsmedizin Berlin
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Sebastian Zschaeck, MD» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

This trial on biomarker validation investigates the use of innovative re-staging FDG-PET

parameters to detect highly chemoradiation (CRT) sensitive squamous cell carcinomas of the

esophagus (SCEC) at the end of preoperative or definitive CRT. Successful validation of this

biomarker could lead to a more individualized approach for patients, i.e. organ preservation

in highly chemoradiosensitive patients. Since favorable response to CRT is associated with

better outcome of patients, the primary endpoint of the study is an improved

event-free-survival (EFS) in responders receiving definitive CRT compared to non-responders.

Additional quality of life and other important endpoints (side effects, overall survival,

local control, occurrence of distant metastases) will be assessed in both treatment groups.

The investigated PET parameters are Maximum standardized uptake ratio (SURmax) of the primary

tumor at week four of chemoradiation and change of maximum standardized uptake value of the

non tumor affected esophagus (DeltaNTO).

To improve the treatment in non-responders in future trials, the study has two additional

scientific support programmes included: Genetic sequencing of tumor tissue to identify

targetable mutations and correlate these with novel imaging biomarkers of none-response on

the one hand (biology based treatment optimization). On the other hand the study will include

an additional observational study arm. In this arm patients with adenocarcinoma of the

esophagus can be included. Our biomarker has only been established in squamous cell

carcinomas, therefore it is an interesting exploratory question, if the parameter can also be

applied to patients with adenocarcinomas of the esophagus. An additional scientific support

program will establish primary tumor cells for better mechanistical understanding of the

imaging biomarkers and testing of treatment according to targetable mutations.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- patients with squamous cell, undifferentiated or adenocarcinoma of the esophagus, UICC

stage II-IVA (maximum T4a)

- ECOG performace status 0-2

- Complete clinical staging, including, esophagogastroscopy, EUS, CT neck/thorax/abdomen

and adequate pulmonary function.

- Adequate hematological, renal, hepatic and pulmonary functions defined as:

granulocytes ≥ 1.5 x 109/l platelets ≥ 100 x 109/l total bilirubin ≤ 1.5 x upper normal

limit creatinine ≤ 120 μmol/L FEV1 ≥ 1.5 L

- Written, voluntary informed consent

- Willingness to perform effective contraceptive practices during treatment for patients

with childbearing potential

Exclusion Criteria:

- Evidence of distant metastases (cM1)

- Prior high-dose radiotherapy to the thorax or abdomen

- Primary tumor cT4b

- history or concurrent malignancy as judged by the treating physician. This is only an

exclusion criterion if the other malignancy is considered the oncological potentially

leading cause of death compared to the esophageal cancer.

Studien-Rationale

Primary outcome:

1. Progression free survival (Time Frame - continiously with two year follow up):
progression free survival is defined as any tumor recurrence (local, regional and or distant) or death

Secondary outcome:

1. Overall survival (Time Frame - continiously with two year follow up):
death of patients

2. loco-regional recurrence free survival (Time Frame - continiously with two year follow up):
time without local or regional tumor recurrence

Geprüfte Regime

Re Staging FDG-PET ([18F]Fluorodeoxyglucose positron emission tomograhpy at week four radiochemotherapy):
Additional interim FDG-PET during week four of preoperative or definitive chemoradiation for esophageal carcinomas. Evaluation of standardized uptake ratio (SUR) and increased uptake of non tumor affected esophagus (Delta NTO).

Quelle: ClinicalTrials.gov

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