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

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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

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE September 25, 2020
Last Update Posted Date April 23, 2021
Actual Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2020)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2020)
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PD-L1 PET Imaging During Neoadjuvant (Chemo)Radiotherapy in Esophageal and Rectal Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Rectal Cancer Stage
  • Oesophageal Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Neoadjuvant Chemoradiotherapy (CRT)
    Interventions:
    • Radiation: CRT
    • Diagnostic Test: PD-L1 PET
  • Short-course preoperative radiotherapy (SCPRT)
    Interventions:
    • Radiation: SCPRT
    • Diagnostic Test: PD-L1 PET
  • Neoadjuvant Chemoradiotherapy (CROSS protocol)
    Interventions:
    • Radiation: CROSS Protocol
    • Diagnostic Test: PD-L1 PET
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04564482
Other Study ID Numbers  ICMJE PETNEC
2020-003142-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johannes Laengle, MD, PhD, Medical University of Vienna
Study Sponsor  ICMJE Johannes Laengle, MD, PhD
Collaborators  ICMJE Christian Doppler Laboratory Applied Metabolomics
Investigators  ICMJE
Principal Investigator: Alexander Haug, MD Division of Nuclear Medicine, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP