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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003142-37 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Chemoradiotherapy (CRT) | Other |
| |
| Short-course preoperative radiotherapy (SCPRT) | Other |
| |
| Neoadjuvant Chemoradiotherapy (CROSS protocol) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT | Radiation | 50 Gy in 2 Gy fractions over 25 working days + capecitabine 1650 mg/m2/d PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pathological therapy response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johannes Laengle, MD, PhD | Contact | +43140400 69260 | johannes.laengle@meduniwien.ac.at | |
| Michael Bergmann, MD | Contact | +43140400 69260 | michael.bergmann@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Haug, MD | Division of Nuclear Medicine, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| SCPRT | Radiation | 25 Gy in 5 Gy fractions over 5 working days |
|
| CROSS Protocol | Radiation | 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 | Diagnostic Test | 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. |
|
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 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |