Combination of salvage surgery and adjuvant photodynamic therapy in management of recurrent or residual sinonasal tumors. - Adjuvant PDT to surgery in recurrent or residual sinonasal tumors.

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•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.

发起方

Antoni van Leeuwenhoek Ziekenhuis