Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04564482
Other study ID # PETNEC
Secondary ID 2020-003142-37
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date June 1, 2026

Study information

Verified date March 2024
Source Medical University of Vienna
Contact Johannes Laengle, MD, PhD
Phone +43140400 69260
Email johannes.laengle@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
CRT
50 Gy in 2 Gy fractions over 25 working days + capecitabine 1650 mg/m2/d PO
SCPRT
25 Gy in 5 Gy fractions over 5 working days
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

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Johannes Laengle, MD, PhD

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intratumoral changes of PD-L1 expression during neoadjuvant CRT/SCPRT Intratumoral PD-L1 expression dynamics induced by neoadjuvant CRT/SCPRT will be assessed by 89Zr-atezolizumab PET imaging (day 0 and between day 10-14). 3 weeks
Secondary Radiographic therapy response Radiographic therapy response will be determined by magnetic resonance imaging-assessed tumor regression grade (mrTRG) for rectal cancer and PET response criteria in solid tumors (PERCIST) for esophageal cancer. 12 weeks
Secondary Pathological therapy response Pathological therapy response will be determined according to the latest American Joint Committee on Cancer/International Union Against Cancer-Tumor Node Metastasis (AJCC/UICC-TNM) staging and tumor regression grade (TRG). 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05685862 - Laser Speckle Contrast Imaging, Surgical Eye & ICG Fluorescence Imaging for Perfusion Assessment of the Gastric Conduit
Recruiting NCT01795768 - Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours Phase 2
Completed NCT05266300 - Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines.
Recruiting NCT03978377 - Cardiopulmonary Toxicity of Thoracic Radiotherapy
Active, not recruiting NCT03653052 - Do Changes in ctDNA Predict Response for Patients With Oesophageal Cancer Receiving Durvalumab Phase 2
Recruiting NCT05489250 - The PLATON Network
Recruiting NCT04484636 - PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) N/A
Terminated NCT01795976 - NY-ESO-1 T Cells in OG Cancer Phase 2
Recruiting NCT01843829 - A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer Phase 2
Completed NCT02382237 - Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition N/A
Completed NCT01915693 - ROCS (Radiotherapy After Oesophageal Cancer Stenting) Study Phase 3
Recruiting NCT04517448 - Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy
Recruiting NCT04232735 - Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE) N/A
Recruiting NCT05642819 - REVOLUTION Surgery (REVOLUTION Surgery)
Recruiting NCT04001478 - Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
Recruiting NCT02741856 - Study of Chemoradiotherapy in Oesophageal Cancer Including PET Response and Dose Escalation Phase 2/Phase 3
Not yet recruiting NCT05600608 - Augmentation of Volatile Biomarkers of Oesophageal and Gastric Adenocarcinoma From the Tumour Lipidome N/A
Recruiting NCT04481256 - TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY N/A
Recruiting NCT05057013 - HMBD-001 in Advanced HER3 Positive Solid Tumours Phase 1/Phase 2
Not yet recruiting NCT06046846 - Prehabilitation Via a Mobile Application in Oesophago-gastric Cancer N/A