Stereotactic radiosurgery for head and neck tumors

Escalating a Biological Dose of Radiation in the Target Volume Applying Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours

This study is testing a new type of focused radiation treatment for people with head and neck tumors to see if it works better and is safer than standard radiation methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Gliwice, Gliwicw)
• Trial ID: NCT06472570 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a stereotactic radiotherapy boost in patients with head and neck tumors, specifically targeting squamous cell carcinoma and other malignant and nonmalignant tumors. The research aims to assess how this innovative approach influences tumor response and normal tissue response through various blood parameters. If successful, this method could potentially replace traditional radiation techniques, leading to more effective treatment options for patients.

Who should consider this trial

Good fit: Ideal candidates include patients aged 18-80 with specific types of head and neck tumors who are eligible for radical radiotherapy or radiochemotherapy.

Not a fit: Patients with head and neck tumors not qualifying for radical treatment or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide more effective treatment options for patients with head and neck cancer.

How similar studies have performed: Other studies have shown promise with stereotactic radiotherapy approaches, indicating potential for success in this novel application.

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

Where this trial is running

Gliwice, Gliwicw

• 1st Radiation and Clinical Oncology Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch, — Gliwice, Gliwicw, Poland (Recruiting)

Study contacts

• Principal investigator: Paweł Polanowski — Maria Sklodowska-Curie National Research Institute of Oncology in Gliwice
• Study coordinator: Paweł Polanowski, PhD

Conditions Head and Neck Cancer; stereotactic radiotherapy; radiosurgery boost; head and neck cancer