Combination of salvage surgery and adjuvant photodynamic therapy in management of recurrent or residual sinonasal tumors.
- Conditions
- paranasal malignancies / mid-face tumors1002765610019190
- Registration Number
- NL-OMON43342
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 0
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 <= 3
5. Eligibility to undergo general anesthesia.
6. Written informed consent.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is to guarantee the delivery of a homogeneous light<br /><br>dose of around 20 ± 5 joule/cm2 at the target region by developing, validating<br /><br>and clinically evaluating an accurate and specific treatment method making use<br /><br>of dosimetry and spectroscopy measurements. Translational research including<br /><br>augmented 3D endoscope imaging, haptic feedback and a mechatronic support aid<br /><br>will be explicitly tested ex vivo and in vivo on feasibility, safety and usage. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameter is to evaluate the safety and tolerability of PDT<br /><br>of the paranasal sinuses by monitoring the adverse side effects such as<br /><br>prolonged systemic photosensitivity, infections etc. according to the common<br /><br>terminology criteria for adverse events v4.0 (CTCAE). No major complications of<br /><br>CTCAE grade 5 and nog more than 20% grade 3-4 complications will be considered<br /><br>as positive result. The preliminary study did not show a grade 5 toxicity,<br /><br>therefore we expect no grade 5 toxicity in this study.<br /><br><br /><br>Effectiveness will be evaluated using recurrence-free survival and<br /><br>recurrence-free survival analysis. Local tumor control will be measured at 3<br /><br>and 6 months after treatment by MRI or CT. Changes within patient*s quality of<br /><br>life will be objectified using European Organization for Research and Treatment<br /><br>of Cancer (EORTC) questionnaires. </p><br>