paranasal malignancies / mid-face tumors
Conditions
Interventions
PDT treatment after salvage surgery.
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Eligibility reviewed and approved by an interdisciplinary hospital team. 2. Age >= 18 years. 3. Histopathological or cytological confirmed diagnosis of recurrent or residual tumor of the sinonasal cavity, maxillary sinus or anterior skull base, considered unsuitable for radical surgery or radiotherapy with curative intent. Patients with distant or regional metastatic disease may be eligible if local palliation is needed. 4. Performance status according to the Eastern Cooperative Oncology Group (ECOG) performance scale
Exclusion criteria
Exclusion criteria: 1. Other concurrent anticancer therapies. 2. Current or recent (within 30 days of first study treatment) participation in another investigational study. 3. Treatment with a medicinal product with known or potential drug-drug interaction with m-THPC. 4. Conditions that worsen when exposed to light (including porphyria). 5. Inability to undergo CT or MR imaging. 6. Pregnancy or lactation (female patients with childbearing potential). A serum pregnancy test has to be performed within 7 days prior to study treatment start. 7. Known allergy or sensitivity to photosensitizers. 8. Ataxia telangiectasia. 9. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, physical examination or laboratory findings) that may interfere with the planned PDT treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is to guarantee the delivery of a homogeneous light dose of around 20 ± 5 joule/cm2 at the target region by developing, validating and clinically evaluating an accurate and specific treatment method making use of dosimetry and spectroscopy measurements. Translational research including augmented 3D endoscope imaging, haptic feedback and a mechatronic support aid will be explicitly tested ex vivo and in vivo on feasibility, safety and usage. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameter is to evaluate the safety and tolerability of PDT of the paranasal sinuses by monitoring the adverse side effects such as prolonged systemic photosensitivity, infections etc. according to the common terminology criteria for adverse events v4.0 (CTCAE). No major complications of CTCAE grade 5 and nog more than 20% grade 3-4 complications will be considered as positive result. The preliminary study did not show a grade 5 toxicity, therefore we expect no grade 5 toxicity in this study. Effectiveness will be evaluated using recurrence-free survival and recurrence-free survival analysis. Local tumor control will be measured at 3 and 6 months after treatment by MRI or CT. Changes within patient*s quality of life will be objectified using European Organization for Research and Treatment of Cancer (EORTC) questionnaires. | — |
Countries
Netherlands
Outcome results
None listed