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RECRUITING
NCT04564482
NA

PD-L1 PET Imaging During Neoadjuvant (Chemo)Radiotherapy in Esophageal and Rectal Cancer

Sponsor: Johannes Laengle, MD, PhD

View on ClinicalTrials.gov

Summary

The overall aim of this pilot study is to prospectively monitor programmed death-ligand 1 (PD-L1) expression dynamics in vivo, during neoadjuvant chemoradiotherapy (CRT) or short-course preoperative radiotherapy (SCPRT) in rectal and esophageal cancer by a positron emission tomography (PET) imaging approach.

Official title: Programmed Death-ligand 1 Positron Emission Tomography Imaging During Neoadjuvant (Chemo)radiothErapy in Esophageal and Rectal Cancer (PETNEC): a Prospective Non-randomized Open-label Single-center Pilot Study

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-11-01

Completion Date

2026-06-01

Last Updated

2024-03-15

Healthy Volunteers

No

Interventions

RADIATION

CRT

50 Gy in 2 Gy fractions over 25 working days + capecitabine 1650 mg/m2/d PO

RADIATION

SCPRT

25 Gy in 5 Gy fractions over 5 working days

RADIATION

CROSS Protocol

41.4 Gy in 1.8 Gy fractions over 23 working days + carboplatin AUC of 2 mg/ml/min + paclitaxel 50 mg/m2 IV Q1W

DIAGNOSTIC_TEST

PD-L1 PET

10 mg atezolizumab IV followed by 37 MBq 89Zr-atezolizumab IV. PET imaging will be done before neoadjuvant CRT/SCPRT (day 0) and between day 10-14 during CRT/SCPRT.

Locations (1)

Medical University of Vienna

Vienna, Austria