An Open-label, Single Arm, Multi-centre, Phase II Study to Evaluate the Safety and Efficacy of PC-A11 With Superficial and Interstitial Laser Light Application in Patients With Recurrent Head and Neck Squamous Cell Carcinoma Unsuitable for Surgery and Radiotherapy
Approximately 650 000 new cases of head and neck cancer are diagnosed worldwide each year
(2). Europe alone, it is estimated that there are approximately 143 000 new cases and more
than 68 000 deaths each year (3). The vast majority (>90%) of head and neck malignancies are
squamous cell carcinomas. Most (60-70%) patients with squamous cell carcinoma of the head
and neck (SCCHN) present with loco regionally advanced disease (2).
Standard treatment options for SCCHN include surgery, radiotherapy and chemotherapy.
Single-modality treatment with surgery or radiotherapy is generally recommended for the 40%
of patients who present stage I or II disease. Each of the two modalities results in similar
survival with cure rates ranging between 60% and 90% (3).
For the 60% of the patients who present with locally advanced disease at diagnosis, combined
modality therapy is generally recommended. For patients with unresectable disease the
current standard treatment is concurrent cisplatin-based chemoradiation. This is also the
standard for patients with resectable disease when organ preservation is desired and, as
adjuvant treatment, for patients with high-risk pathological findings at surgical resection.
Despite such an approach, a substantial percentage of patients (20-30%) develop local and/or
regional recurrences and distant metastases (3). Recurrent disease is often not resectable,
and even in resectable cases, some patients decline the surgical procedure due to quality of
life considerations. Additionally, in recurrent disease the radiation tolerance of the
normal tissues makes re-irradiation technically challenging and frequently more toxic than
the initial course (4). The prognosis of patients with recurrent or metastatic SCCHN is
generally poor, with a median survival of 6-9 months (5).
The therapeutic ratio in recurrent SCCHN is narrow. Therefore, there is a large unmet
medical need for novel treatments in this patient group, both to lengthen overall survival,
and to improve the patients' quality of life
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicities (DLT)
The 'run-in part' primary endpoint
3 months
Yes
Baris Karakullukcu, MD
Principal Investigator
The Netherlands Cancer Institute
Germany: Federal Institute for Drugs and Medical Devices
PCIA202/10
NCT01606566
April 2012
May 2015
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