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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564482
Recruitment Status : Active, not recruiting
First Posted : September 25, 2020
Last Update Posted : April 23, 2021
Sponsor:
Collaborator:
Christian Doppler Laboratory Applied Metabolomics
Information provided by (Responsible Party):
Johannes Laengle, MD, PhD, Medical University of Vienna

Brief 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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Stage Oesophageal Cancer Radiation: CRT Radiation: SCPRT Radiation: CROSS Protocol Diagnostic Test: PD-L1 PET Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Neoadjuvant Chemoradiotherapy (CRT) Radiation: CRT
50 Gy in 2 Gy fractions over 25 working days + capecitabine 1650 mg/m2/d PO

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.

Short-course preoperative radiotherapy (SCPRT) Radiation: SCPRT
25 Gy in 5 Gy fractions over 5 working days

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.

Neoadjuvant Chemoradiotherapy (CROSS protocol) 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.




Primary Outcome Measures :
  1. Intratumoral changes of PD-L1 expression during neoadjuvant CRT/SCPRT [ Time Frame: 3 weeks ]
    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).


Secondary Outcome Measures :
  1. Radiographic therapy response [ Time Frame: 12 weeks ]
    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.

  2. Pathological therapy response [ Time Frame: 12 weeks ]
    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).



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age and older
  • All sexes
  • Histologically confirmed carcinoma of the rectum or oesophagus (squamous cell carcinoma and adenocarcinoma, including oesophago-gastric junction cancers)
  • Medical need for a neoadjuvant CRT/SCPRT
  • Suitable to withstand the course of neoadjuvant CRT/SCPRT
  • Written informed consent form (ICF) for participation in the study

Exclusion Criteria:

  • Metastatic disease, which is considered incurable by local therapies (expect for oligometastatic disease with a curative intend)
  • Previous surgery of the tumor other than biopsy
  • Pregnancy, breastfeeding or expectancy to conceive
  • Prior therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other agent directed against co-inhibitory T cell receptors or has previously participated in clinical studies with immunotherapy
  • Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy
  • Hepatitis B or C
  • Human immunodeficiency virus (HIV)
  • Immunodeficiency
  • Allogeneic tissue or solid organ transplantation
  • Autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, steroids or immunosuppressive drugs
  • Active non-infectious pneumonitis
  • Active infection requiring systemic therapy
  • Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
  • Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin and/or curatively-resected in situ cervical and/or breast cancers
  • Treatment with botanical preparations (i.e. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment
  • Participants with serious or uncontrolled medical disorders
  • Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males > 450 ms and > 470 ms in females, participants with history of myocarditis)
  • Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen)
  • Other exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564482


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Johannes Laengle, MD, PhD
Christian Doppler Laboratory Applied Metabolomics
Investigators
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Principal Investigator: Alexander Haug, MD Division of Nuclear Medicine, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna
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Responsible Party: Johannes Laengle, MD, PhD, Sub-Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04564482    
Other Study ID Numbers: PETNEC
2020-003142-37 ( EudraCT Number )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johannes Laengle, MD, PhD, Medical University of Vienna:
Rectal Cancer
Oesophageal Cancer
Chemoradiotherapy
Short-course preoperative radiotherapy
PD-L1 PET
89Zr-atezolizumab
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases