Clinical trial NCT06472570: Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours
Official title: Escalating a Biological Dose of Radiation in the Target Volume Applying Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: stereotactic radiotherapy
radiosurgery boost
head and neck cancer
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the safety and efficacy of the stereotactic boost applied in patients with H\&N tumours.

Detailed description: Aims of the study:

1. Evaluation of the efficacy of the stereotactic boost applied in patients with head and neck tumours.
2. Evaluation of the safety of the stereotactic boost applied in patients with head and neck tumours.
3. Evaluation of the influence of the stereotactic radiotherapy boost on blood parameters reflecting tumour response (interleukin 6 (Il-6), thymidine kinase (TK), Fms-related tyrosine kinase 1 (sFlt-1)), and normal tissue response (C-reactive protein (CRP)).

In the case of beneficial findings, the stereotactic radiosurgery boost in the course of radio(chemo)therapy in patients with head and neck tumours will be able to replace traditional techniques of radiation, and radical schemes of treatment will be possible for future development.

Eligibility criteria: Inclusion Criteria:

1. Patients with squamous cell carcinoma (SCC) or adenoid cystic carcinoma (ACC) of the H\&N region qualified for radical treatment with (definitive or adjuvant (adjuvant radiotherapy or radiochemotherapy in postoperative cases of R2 resection or early locoregional recurrence unsuitable for reoperation)) radiotherapy or radiochemotherapy.
2. Patients with other malignant tumours of the H\&N region (sarcomas, neuroendocrine carcinomas, differentiated carcinomas, undifferentiated carcinomas, or basaloid carcinomas) qualified for radical treatment with (definitive or adjuvant (adjuvant radiotherapy or radiochemotherapy in postoperative cases of R2 resection or early locoregional recurrence unsuitable for reoperation)) radiotherapy or radiochemotherapy.
3. Patients with nonmalignant tumours of the H\&N region (tumour mixtus or paraganglioma) demanding definitive or adjuvant radiotherapy.
4. Age: 18-80 years. Biomedicines 2022, 10, 1484 5 of 12
5. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
6. Conscious agreement to participate in the clinical trial.

Exclusion Criteria:

1. Do not meet the inclusion criteria.
2. Decompensated diabetes mellitus.
3. Myocardial infarction occurred up to 6 months before.
4. Pregnancy.
5. Mental disorder preclusive of making a conscious agreement

Primary outcomes:
measure: Response to treatment
timeFrame: one month after the end of treatment, every 3 months in the first year, every 4 months in the second year, and every six months in the third-fifth years
Secondary outcomes:
measure: Evaluation of efficacy
timeFrame: 5 years after the end of treatment
measure: Evaluation of efficacy
timeFrame: 5 years after the end of treatment
measure: Evaluation of efficacy
timeFrame: 5 years after the end of treatment
measure: Evaluation of safety Terminology Criteria for Adverse Events (CTCAE)v4.0.
timeFrame: 5 years after the end of treatment
measure: Treatment tolerance
timeFrame: an average of 3 months
Other outcomes:
Locations:
city: Gliwice
country: Poland
facility: 1st Radiation and Clinical Oncology Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch,
state: Gliwicw
Study officials:
affiliation: Maria Sklodowska-Curie National Research Institute of Oncology in Gliwice
name: Paweł Polanowski
role: PRINCIPAL_INVESTIGATOR
References: