Olaparib for Head and neck squamous cell carcinoma

Inclusion criteria

• {"criterion_text":"- Patients >18y, with biopsy-proven HPV-negative HNSCC, or patients >40y with HPV-positive HNSCC and high-risk features (i.e. > 10 smoke packs/year AND ≥N2b)\n- Treatment with chemoradiotherapy using platinum-based chemotherapy is anticipated\n- Recent archival tumour tissue (<8 weeks prior to inclusion) should be available with sufficient residual material for determination of tumour PARP1 levels\n- Presence of a tumour lesion ≥10 mm in diameter\n- ECOG performance status 0-2\n- Negative pregnancy test in women with childbearing potential\n- Life expectancy >3 months\n- Signed written informed consent and able to comply with the protocol\n- For stage II only: re-biopsy should be deemed feasible by the investigators (as-sessed by head-and-neck surgeon)"}

Exclusion criteria

• {"criterion_text":"- Recent treatment with PARP inhibitors or other investigational therapies <30 days.\n- Presence of significant co-morbidities that make participation in the study undesirable according to the treating physician."}

Primary endpoints

• {"endpoint_text":"- \tDose-activity curves for healthy organs","definition_or_measurement_approach":"Dosimetry assessment of radiotracer uptake in healthy organs to generate dose-activity curves."}
• {"endpoint_text":"- \tTumour: background ratio at different timepoints post-injection","definition_or_measurement_approach":"Measurement of tumour-to-background uptake ratios of [18F]-olaparib at multiple timepoints after injection."}
• {"endpoint_text":"- \tAEs until 30 days post-injection","definition_or_measurement_approach":"Recording of adverse events occurring up to 30 days after tracer injection."}
• {"endpoint_text":"- \tCorrelation between standardised uptake value of [18F]-olaparib in tumour lesions, and PARP1 expression levels determined by immunohistochemistry","definition_or_measurement_approach":"Correlation analysis between tumour SUV measured by PET and PARP1 expression levels quantified by immunohistochemistry on tumour biopsy samples."}

Secondary endpoints

• {"endpoint_text":"- \tAbsolute and percentage increase in tumour [18F]-olaparib standardised uptake value after one week of chemoradiation compared to baseline tumour [18F]-olaparib standardised uptake value.","definition_or_measurement_approach":"Comparison of tumour SUV at baseline and after one week of chemoradiation to calculate absolute and percent changes."}
• {"endpoint_text":"- \tCorrelation between standardised uptake value of [18F]-olaparib in tumour lesions, and PARP1 expression levels determined by immunohistochemistry after one week of chemoradiation.","definition_or_measurement_approach":"Correlation analysis between tumour SUV after one week of chemoradiation and PARP1 expression measured by immunohistochemistry."}

Netherlands

Earliest CTIS Part Ii Submission Date

10-04-2025

Latest Decision Or Authorization Date

22-04-2025

Processing Time Days

12

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands