Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours

Trial Title: Stereotactic Radiosurgery in Patients With Head and Neck Region Tumours

NCT ID: NCT06472570

Condition: Head and Neck Cancer

Conditions: Official terms:
Head and Neck Neoplasms

Conditions: Keywords:
stereotactic radiotherapy
radiosurgery boost
head and neck cancer

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Stereotactic radiotherapy boost
Description: A stereotactic radiosurgery boost is given in two cases: - Upfront boost-on the first day of overall treatment time (OTT) (to 6 days before beginning conventional radiotherapy). - Direct boost-on Days 43-49 of OTT in relation to conventional radiotherapy to total dose (TD) 70 Gy, i.e., up to 6 days after a dose of 60 Gy. Treatment is conducted as radiotherapy alone or radiochemotherapy based on cisplatin 100 mg/m2 or 40 mg/m2 in a 21-day or 7-day cycle, respectively Patients who start the treatment from induction chemotherapy may have a chance to qualify for an upfront or direct boost, depending the evaluation of the response to systemic treatment Prescribed doses of stereotactic boost are in the range of 10-18 Gy
Arm group label: Stereotactic radiotherapy

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: 1st Radiation and Clinical Oncology Department, Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice Branch,

Address:
City: Gliwice
Zip: 44-102
Country: Poland

Status: Recruiting

Contact:
Last name: Pawel Polanowski

Phone: 48322788313
Email: pawel.polanowski@gliwice.nio.gov.pl

Investigator:
Last name: Pawel Polanowski, PhD
Email: Principal Investigator

Start date: October 26, 2019

Completion date: December 31, 2030

Lead sponsor:
Agency: Maria Sklodowska-Curie National Research Institute of Oncology
Agency class: Other

Source: Maria Sklodowska-Curie National Research Institute of Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06472570