NCT04564482

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Johannes Laengle, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer Stage
• Oesophageal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2020-09-25
• Last updated: 2024-03-15

Locations

1 site across 1 country: Austria