Escalating a Biological Dose of Radiation in the Target Volume Applying Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Response to treatment
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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.
- •Patients with nonmalignant tumours of the H\&N region (tumour mixtus or paraganglioma) demanding definitive or adjuvant radiotherapy.
- •Age: 18-80 years. Biomedicines 2022, 10, 1484 5 of 12
- •Performance status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Conscious agreement to participate in the clinical trial.
Exclusion Criteria
- •Do not meet the inclusion criteria.
- •Decompensated diabetes mellitus.
- •Myocardial infarction occurred up to 6 months before.
- •Mental disorder preclusive of making a conscious agreement
Outcomes
Primary Outcomes
Response to treatment
Time Frame: 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
Response to treatment in imaging tests and clinical examination-local control (LC) and locoregional control (LRC).
Secondary Outcomes
- Treatment tolerance(an average of 3 months)
- Evaluation of safety Terminology Criteria for Adverse Events (CTCAE)v4.0.(5 years after the end of treatment)
- Evaluation of efficacy(5 years after the end of treatment)