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JOURNAL ONKOLOGIE – STUDIE

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

Noch nicht rekrutierend

NCT-Nummer:
NCT04564482

Studienbeginn:
Dezember 2020

Letztes Update:
25.09.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Rectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Johannes Laengle, MD, PhD

Collaborator:
Christian Doppler Laboratory Applied Metabolomics

Studienleiter

Alexander Haug, MD
Principal Investigator
Division of Nuclear Medicine, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna

Kontakt

Studienlocations (1 von 1)

Medical University of Vienna
1090 Vienna
Austria» Google-Maps
Ansprechpartner:
Johannes Laengle, MD, PhD
Phone: +43 1 40400 69260
E-Mail: johannes.laengle@meduniwien.ac.at

Michale Bergmann, MD
Phone: +43 1 40400 69260
E-Mail: michael.bergmann@meduniwien.ac.at
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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).

Studien-Arme

  • Other: Neoadjuvant Chemoradiotherapy (CRT)
  • Other: Short-course preoperative radiotherapy (SCPRT)
  • Other: Neoadjuvant Chemoradiotherapy (CROSS protocol)

Geprüfte Regime

  • 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
  • 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.

Quelle: ClinicalTrials.gov


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