Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours

Maria Sklodowska-Curie National Research Institute of Oncology

Status: Enrolling

Conditions: Head and Neck Cancer

Treatments: Radiation: Stereotactic radiotherapy boost

Study type: Interventional

Funder types: Other

Identifiers

NCT06472570

SterRad

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Stereotactic radiotherapy

Experimental group

Description:

Patients treated with stereotactic radiosurgery boost. Treatment is conducted as radiotherapy alone or radiochemotherapy based on cisplatin

Treatment:

Radiation: Stereotactic radiotherapy boost